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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-60.0, Chronic Hepatitis C Chronically infected with Hepatitis C Virus (HCV) genotype 1 Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus HCV RNA viral load of ≥10*5 IU/mL BMI 18 to 35kg/m² Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection HIV and/or HBV positive Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug WOCBP will be enrolled as in-patient for 16 days
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Chronic Hepatitis C Infection Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance Patients with baseline monitoring of emotional state and neurocognitive performance According to SPC According to legal requirements reg. drug substitution therapy (BTMVV) Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance) Age under 18 years or over 65 years coinfections such as hepatitis B virus or human immunodeficiency virus
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Hepatitis C, Chronic Diagnosed with chronic hepatitis C Minimum 20 years of age Willing to use adequate contraception during the course of the study Participants who can be hospitalized for at least 14 days since treatment initiation Positive for HCV genotype 1 (genotype 1a and 1b) with high viral load (HCV-RNA >=100 kIU/mL) Participants weighing over 40 kg to 50 kg Hematology results of hemoglobin levels >=12 g/dL neutrophils >=1,500/mm^3 platelets >=100,000/mm^3 Previous ribavirin therapy Previous interferon therapy within 90 days of registration Participants who received treatment with injectable products containing glycyrrhizin/cysteine/glycine (Stronger Neo-Minophagen C, etc.), Shosaikoto, or ursodeoxycholic acid within 30 days before the start of treatment Participants who received treatment with an antiviral or anti-tumor drug or who received immunomodulating therapy (including steroids and radiotherapy) within 90 days before the start of treatment [excluding local administration and topical drugs] Participants who received other investigational drugs within 180 days before the start of treatment Hepatitis Bs (HBs) antigen-positive Antinuclear antibodies >=1:160 Fasting blood glucose >=110 mg/dL (however, participants with fasting blood glucose of 110 mg/dL to <126 mg/dL can be registered if HbA1c is <6.5%) Participants diagnosed with liver cirrhosis in most recent celioscopy or liver biopsy Participants with or who have a history of any of the following: liver failure; hepatic encephalopathy, esophageal varices, or ascites; depression or schizophrenia requiring treatment or suicidal attempt or ideation; epileptic seizures requiring drug treatment; autoimmune disease (such as Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, and scleroderma); hepatic cancer
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Autoimmune Hepatitis De novo autoimmune hepatitis Consent age below 18 pregnancy
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatitis C, Chronic Hepacivirus HIV Infections Previously untreated chronic hepatitis C with HCV-RNA positive in plasma Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of normal Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell) count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic at the Entry visit Alpha-fetoprotein value within normal limits obtained within one year prior to entry. Results above the upper limit of normal but <=50 ng/mL require both of the following: Alpha-fetoprotein value <=50 ng/mL obtained within 3 months prior to entry in the study and Ultrasound obtained within 3 months prior to entry in the study or that is negative for evidence of hepatocellular carcinoma Liver biopsy (optional) within 12 months prior to study entry with a pathology report confirming that the histologic diagnosis is consistent with chronic hepatitis Women of childbearing potential must be using an acceptable method of birth control or be surgically sterilized Reconfirmation that sexually active males must be practicing acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy Subjects must be free of any clinically significant diseases other than hepatitis or HIV infection that would interfere with study evaluations Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis Participation in any other clinical trial within 30 days of entry to this protocol Treatment with any investigational drug within 30 days of entry to this protocol Subjects with organ transplants other than cornea and hair transplant Any cause for the liver disease based on subject history and biopsy (where applicable) other than chronic hepatitis C, including but not limited to coinfection with hepatitis B virus (HBV); hemochromatosis (iron deposition >2+ in liver parenchyma); alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy Hemoglobinopathies (eg, Thalassemia) Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, and encephalopathy Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Insulin Resistance Chronic hepatitis C patients with positive anti-HCV for more than 6 months and HCV RNA 2. No overt hepatic failure or decompensated liver cirrhosis (Child-Pugh class B or C) or hepatocellular carcinoma Positive for hepatitis B surface antigen (HBsAg)or with concomitant human immunodeficiency virus infection 2. With other types of hepatitis including autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, Wilson's disease, alpha 1-antitrypsin deficiency 3. Current or past history of alcohol abuse (80 mL ethanol per day)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Hepacivirus Adult patients with hepatitis C According to the products' labeling (refer to Warnings, contraindications, and safety sections)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hepatitis C, Chronic Hepatitis C Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania Not applicable
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Hepacivirus Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C Concomitant participation in a clinical trial for the treatment of hepatitis C
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 12.0-999.0, Hepatitis C Hemophilia HCV RNA positive Age older than 12 years Ongoing pregnancy or breast feeding Hx of HCC Hx of alcoholic liver disease Hx of bleeding from esophageal varices Hx of hemochromatosis Hx of autoimmune hepatitis Hx of Suicidal attempt Hx of cerebrovascular dis Hx of severe retinopathy Hx of severe psoriasis
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 12.0-999.0, Hepatitis C Thalassemia HCV RNA positive Age older than 12 years Ongoing pregnancy or breast feeding History (Hx) of Hepatocellular Carcinoma (HCC) Hx of alcoholic liver disease Hx of bleeding from esophageal varices Hx of hemochromatosis Hx of autoimmune hepatitis Hx of Suicidal attempt Hx of cerebrovascular dis Hx of severe retinopathy Hx of severe psoriasis
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Willingness to participate years or older, either gender, any race Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1 Subject considered suitable for treatment per local label Investigator considers suitable and subject consents to be treated Does not show negative polymerase chain reaction [PCR] at week 4 Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the Summary of Product Characteristics [SmPC]
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Age 18 years or above, male or female Presence of HCV RNA (with or without anti-HCV) in serum at levels of at least 10,000 IU/ml. Willingness to undergo liver biopsy before or 6 hours after an initial injection of peginterferon. Written informed consent Previous adequate treatment with any form of type I interferon (standard alpha interferon, peginterferon, beta interferon). Adequate treatment is considered at least 12 weeks of therapy. Other antiviral therapy within the last 6 months. If cirrhosis is present, decompensated liver disease, as marked by bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Serum ALT or AST levels greater than 1000 micro/L (greater than 25 times ULN). Such patients will not be enrolled but may be followed until three consecutive determinations are below this level. Pregnancy or current breastfeeding. In women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device until 6 months after the end of treatment with ribavirin given the potential for teratogenicity. Significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (HIV) infection, and angina pectoris. Pre-existing anemia (hematocrit less than 33 percent) or known history of hemolytic anemia. In patients in Groups C and D, liver biopsy will not be performed if hemoglobin levels fall to below 11 g/dl during ribavirin monotherapy. Epopoetin alfa or darbopoietin alfa therapy will be available to achieve an adequate hematocrit if clinically indicated for patients in all groups. Immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily on a chronic basis) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine). Patients receiving a short-course of corticosteroids for acute allergic reactions or asthma or chronic obstructive pulmonary disease exacerbations (less than 2 weeks of therapy) will be eligible for the study after 4 weeks off therapy. Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency). Patients with concomitant non-alcoholic steatohepatitis but no other form of chronic liver disease will not be excluded from this study. Evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year. Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. Clinical gout. Active, serious autoimmune disease such as systemic lupus erythematosis, ulcerative colitis, Crohn s disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alpha interferon. These are considered the standard relative contraindications to peginterferon and ribavirin therapy
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Treatment naive (no prior treatment with IFN-a +/ RBV regimens Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive HCV RNA > 100,000 IU/mL at screening Genotype 1 A diagnosis of chronic HCV infection for at least 6 months Evidence of acute or chronic infection with HIV or HBV Exposure within the previous three months to an investigational anti-HCV agent Evidence of severe or decompensated liver disease Subjects with liver disease unrelated to HCV infection
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Infection anti-HCV positive HCV RNA positive contraindications for antiviral treatment concurrent chronic viral infections
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Hepatitis C Before all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin According to Peginterferon alfa-2b/Ribavirin label
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis C, Chronic The patient must demonstrate his/her continued willingness to participate in the study The patient must be at least 18 years of age, of either gender Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + Ribavirin as first treatment for hepatitis C Negative HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate) Patients treated for a period shorter than the enrollment period Patients co-infected with human immunodeficiency virus (HIV) Patients co-infected with hepatitis B virus (HBV) Patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Adult patients with hepatitis C According to the products' labeling
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, HIV Hepatitis C Infections Diagnosis of HCV with detectable HCV RNA in serum Meets clinical for initiating HCV therapy Lives in the community and not in a board and care, nursing home, hospice, or other residential setting in which a professional caregiver would dispense necessary medication. Living with a partner, roommate, or other family members who may assist with caregiving, including reminding participants to take medication, is acceptable Responsible for administering own medications Diagnosis of HIV-associated neurocognitive disorder (HAND) will not be cause for so long as participant is able to demonstrate the ability to grant full informed consent HIV or HCV disease severity will not be cause for (e.g., CDC Groups A, B, and C are all eligible); although, if severely ill because of either HIV (e.g., uncontrolled viremia, severely immunosuppressed) or HCV (e.g., cryoglobulinemia, hepatic encephalopathy) will not be eligible for PEG-IFN/RBV therapy Able to read English at the 6th grade level Current or past psychotic spectrum disorder, including schizophrenia, schizophreniform disorder, or bipolar disorder History of learning disability, seizure disorder, closed-head injury with loss of consciousness in excess of 30 minutes, or any other neurological disease Evidence of any central nervous system opportunistic infection or neoplasm Diagnosed with Hepatitis B Previous failed course of HCV therapy Those judged to be significantly depressed by the study psychiatrists/psychologists (defined as current major depressive disorder of moderate or severe severity) or with evidence of suicidal ideation will not be enrolled until clinical condition is stabilized
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Arthritis, Rheumatoid Patients, between 18 and 70 years of age Clinical diagnosis of RA, based on typical history and clinical presentation of the patient according to the diagnostic of the American College of Rheumatology (ACR), 1987 Active AR characterized by pain and increase in joint volume, in at least 1 joint, associated to VHS > 20 mm/h and/or PCR > 0,6 ng/ml Ambulatory patient requiring treatment with anti-inflammatory drugs, whom is neither receiving non-steroidal anti-inflammatory drugs (NSAIDs) nor any other drugs, except Paracetamol, for at least 4 weeks previous to the beginning of the study Also, patients with RA treated with Prednisone and/or Chloroquine and Methotrexate in stable doses for at least 6 weeks, with active arthritis, and willing to participate in the study Willing to come to regular controls Written consent signed by the patient, according to the and text approved by the local Scientific Ethical Committee Pregnant women, breast feeding, childbirth, potentially fertile and / or not following adequate contraceptive methods Non degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA (i.e. Gout, Pseudogout, Chondrocalcinosis, Psoriatic Arthritis, Infectious Arthritis, Reactive Arthritis or Spondylitic Arthritis) Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients Treatment with intra-joint injection with corticosteroids one month before treatment Ongoing treatment with anticoagulants, hydantoins or lithium Presence or history of digestive hemorrhage, peptic ulcer in the 6 previous months or hemorrhagic ulcer any time during the past, gall bladder stones or dysfunction Hypersensitivity and / or intolerant to NSAIDs, including patients with bronchospam history induced by Aspirin Evidence of renal, hepatic and severe hematopoietic diseases, and heart failure revealed by laboratory tests or other tests History of using any other test drug, one month before to the beginning of this trial Patients with tranquilizers, hypnotic or excess of alcohol, which can interfere with the perception of pain
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Mental Disorders Drug Addiction Medical were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase (ALT > 30 U/L, normal <24 U/L) General were the presence of other liver disease Child B or C cirrhosis Severe cardiac or neurological disease Co-infection with hepatitis B or HIV Hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein Autoimmune disorders Neutrophil count below 1500 per cubic millimetre Platelet count below 75000 per cubic millimetre
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatocellular Carcinoma Hepatitis B Virus Recurrence patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma 2. patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis. 3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative previous history of antiviral therapy 2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher 3. positive for anti-HCV or anti-HIV 4. Child-Pugh classification B or C after surgery 5. preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds 6. signs showing recurrence or metastasis oen month after surgery 7. underlying cardiac or renal diseases
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hepatocellular Carcinoma Hepatitis B Virus patients with hepatocellular carcinoma caused by hepatitis B virus without antiviral drug treatment and patients will be treated by transcatheter arterial chemoembolization patients already received antiviral drug management
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Chronic Hepatitis C HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction Histological diagnosis of chronic hepatitis Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment Age between 18 and 65 years Ability to provide informed consent Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g) Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) Pregnancy or lactation Decompensated cirrhosis Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml Refusal to participate in the study Concomitant disease with reduced life expectancy Severe psychiatric conditions Drug dependence Co-infection with hepatitis A or B or HIV Pregnancy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-60.0, Hepatitis C, Chronic Cognition Disorders Fatigue Syndrome, Chronic Major Depressive Disorder Chronic HCV infection with genotype 1, 2, 3 or 4 Age > 18 and <60 Liver biopsy or fibroscan performed within last 5 years Signed informed consent form Liver biopsy showing liver pathology not due to HCV infection Liver cirrhosis or severe liver fibrosis Former antiviral HCV treatment (for included HCV patients) HIV and/or Hepatitis B virus infection Alcohol or drug abuse within the last 2 years Neutropenia, anemia or thrombocytopenia Clinical signs of non-compensated liver pathology Moderate to severe cardiopulmonary disease (NYHA score 1 or above) Creatinine clearance < 80mL/min Pregnancy
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-60.0, Chronic HCV Infection Nonalcoholic Steatohepatitis chronic HCV infection must undergo liver biopsy must undergo antiviral treatment liver sample not obtained blood samples for HCV testing not obtained in specified time points during antiviral therapy
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Human Immunodeficiency Virus HIV Infections Newly acquired HCV infection of 6 months or less duration Detectable HCV RNA at study entry HIV infection, any CD4 count Pregnant or intent to become pregnant within 24 weeks of study completion Uncontrolled depression Other serious liver disease Other safety parameters must be met
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Alcoholic Hepatitis Patients must be chronic alcohol users, defined by a history of ethanol consumption on average > 40g/day for women and 60g/day for men for at least 1 year before inclusion The presumptive diagnosis for alcoholic hepatitis will be: recent binge drinking; compatible physical findings (one or more: jaundice, enlarged liver, hepatic bruit, abdominal pain, loss of appetite, nausea); and a compatible biochemical profile (moderate elevation of AST over ALT, elevated total serum bilirubin); or a liver-spleen colloid scan suggestive of reticulo-endothelial redistribution and hepatic arterialization The diagnosis of alcoholic hepatitis must be confirmed on liver biopsy, showing typical features of acute sclerosing hyaline necrosis 70 The degree of portal fibrosis as determined on liver biopsy, graded according to the Knodell score-modified by Ishak 71 must be less than or equal to 5 out of a possible score of 6, 6 indicating cirrhosis The alcoholic hepatitis must be "stable", i.e. not requiring treatment by either pentoxifylline 72 or prednisone, with a Maddrey Score 73 {(PTpatient PTcontrol) x 4.6 + TBmg/dL} < 32 Patients must be willing to participate in the trial, remain abstinent to alcohol, and compliant to the treatment regimen, and undergo a post-treatment liver biopsy Patients who have either compensated cirrhosis (biopsy proven) or a clinical picture of severe cirrhosis defined as Child's class C and/or with a recent history (within one month) of decompensated liver disease (history of ascites, encephalopathy or variceal bleeding within one month of trial entry). These patients have reduced life expectancy below one year and are most often severely coagulopathic and cannot be biopsied Patients who have severe acute alcoholic hepatitis of poor prognosis defined as a Maddrey Score > 32. These patients have a mortality rate of 50% during their hospitalization period when untreated by either prednisone or pentoxifylline Patients who are receiving hepatotropic treatments such as colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, and pentoxifylline Patients who are receiving known hepatotoxic long-term treatments such as NSAIDs, statins, neuroleptics, certain anti-convulsive medications, or high-dose acetaminophen Patients suspected of having hepatocellular carcinoma Patients who have contra-indications to liver biopsy Patients who have a liver biopsy that does not yield sufficient specimen for analyses Patients who have untreated deficiencies of folic acid, vitamin B6 or B12 Patients who have chronic active Hepatitis B or C, hemochromatosis, autoimmune hepatitis, or a cholangiopathy Patients with psychotic disorders, and in particular manic depression (contra indication to SAMe treatment)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-64.0, Hepatitis C Has chronic genotype 1 Hepatitis C infection Has not tolerated previous course of peg-IFN and ribavirin Has HIV Has Hepatitis B Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis Age over 18 years Weight 85 kg below the pre-inclusion visit Documented HIV infection (HIV positive) HCV infection documented by a positive PCR HCV Genotype 1 or 4 Compensated liver disease (Child-Pugh below/equal to 6) Lymphocytes CD4 above 200/mm3 Patient not answering a treatment for hepatitis C Patient not covered by dual by Peg-IFN + riba for at least three months (wash out) Co-infection with HBV (HBsAg positive) Neutropenia below 1000/mm3 Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3 Hemoglobin below 11 g / dL (men and women) Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatocellular Carcinoma A group of patients with no history of liver disease, alcohol consumption less than 40g a week, and no risk factors for viral hepatitis were enrolled from the General Internal Medicine clinics. All subjects in this control group were documented to have normal liver biochemistry Consecutive patients with HCC and patients with HBV & HCV that were age, gender, and race/ethnicity matched to the HCC patients were enrolled from the Liver Clinic during this period. The diagnosis of HCC was made by histopathology, and if histopathology was not available by two imaging modalities (ultrasound [US], magnetic resonance imaging [MRI], or computed tomography) showing a vascular enhancing mass >2cm. HBV infection status was based on hepatitis B surface antigen (HBsAg). HCV infection status was based on serum HCV antibody and HCV-RNA positive
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C, Chronic HCV genotype 1 2. HCV viral load >100,000 IU/mL 3. histology or fibroscan to rule out cirrhosis 4. Absence of retinopathy 5. treatment naive patients and treatment experienced patients 6. Age 18 years 7. Male OR female with documented hysterectomy OR postmenopausal Fertile males not willing to use an adequate form of contraception 2. Pretreatment with any HCV-polymerase inhibitor 3. Any concurrent disease if clinically significant based on the investigator's medical assessment 4. Current alcohol or drug abuse, or history of the same 5. Positive test for HIV or HBs 6. History of malignancy 7. Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination 8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer 9. Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening 10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening 11. Known hypersensitivity to drugs or excipients; Further apply
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis D Written informed consent Age > 18 years Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values taken > 1 month apart during the 12 months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose A liver biopsy obtained within the past 12 months demonstrating liver disease consistent with chronic hepatitis. Patients with cirrhosis on liver biopsy must also have a liver imaging investigation to rule out hepatic carcinoma Negative urine or serum pregnancy test documented within the 24 hour period prior to the first dose of test drug Additionally, all fertile males with partners of childbearing age and females should use two reliable forms of effective contraception (combined) throughout the entire period of the study (treatment and for 4 months after treatment completion) Creatinine clearance ≥ 70 mL/min Patients must not have received antiviral therapy for their chronic hepatitis D within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded Positive test at screening for HAV-Ag-IgM, HCV-RNA or HCV-Ag or HIV-Ag Serum concentrations of ceruloplasmin or alpha-1-antitrypsin consistent with an increased risk of metabolic liver disease Evidence of decompensated liver disease (Childs B-C) History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia) Women with ongoing pregnancy or who are breast feeding WBC count of < 3.000 cells/ mm3; neutrophil count < 1.500 cells/mm3or platelet count < 90.000 cells/mm3 Evidence of alcohol and/or drug abuse within one year of entry Patients are excluded if any history of psychiatric disease, especially depression, or of suicidal attempts is evident History of immunologically mediated disease
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C Liver Transplantation Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF Immunosuppresive regimen based on tacrolimus b.i.d (twice or once daily) for at least 6 months prior randomization Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization Serum creatinine >150 μmol/L (1.6 7 mg/dL) or eGFR < 50 ml/min (4-variable Modification of Diet in Renal Disease [MDRD Cockcroft-Gault formula]) Multi-organ transplant recipients Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or >1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia Evidence of conditions that could cause graft dysfunction other than HCV infection Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin <3.5g/dL or, total direct bilirubin >1.5mg/dL or, INR >1.5) Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening Antiviral treatment for HCV administered at any time after liver transplantation Patients on daily doses of corticosteroids higher than 5 mg/day Patients with fibrosing cholestatic hepatitis
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 40.0-65.0, Chronic Hepatitis C Infection Participant is a male or female between 40 to 65 years of age at the prestudy (screening) visit Participant has a Body Mass Index (BMI) ≥18.5 kg/m2 and ≤36.0 kg/m2 Participant requires a diagnostic biopsy, per local treatment guidelines, to monitor progression of liver disease Participant has chronic compensated, genotype 1 HCV infection as defined by positive serology for HCV and detectable HCV RNA in peripheral blood Participant met pre-specified based on laboratory values at screening for the following: - Alanine aminotransferase (ALT): ≤400 U/L - Aspartate aminotransferase (AST): ≤400 U/L - Total bilirubin: ≤2.4 mg/dL - Direct bilirubin: ≤1.0 mg/dL -- Creatinine clearance (Clcr): ≥60 mL/min (by the Cockcroft-Gault equation*) - Albumin: ≥3.3 g/dL - Participant is under the age of legal consent, is mentally or legally incapacitated/ institutionalized, has significant emotional problems at the time of prestudy screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures Participant has a history of stroke, chronic seizures, or major neurological disorder Participant did not achieve a viral response to prior treatment with licensed interferon-based therapy (i.e., is a 'null responder'). Viral response is defined by a >= 2-log^10 decline in HCV viral RNA within the first 12 weeks of therapy Participant has previously been treated with an NS3/4A protease inhibitor for chronic HCV infection Evidence of high grade bridging fibrosis (eg, score >3, Ishak score >4 or Scheuer score >3) from prior liver biopsy within 3 years of study entry Participant has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, nonalcoholic steatohepatitis (NASH), drug-induced hepatitis or autoimmune hepatitis. Note: Participants with history of acute non-HCV-related hepatitis which resolved >6 months before study entry can be enrolled Participant has clinical or laboratory evidence of cirrhosis or other advanced liver disease Participant has decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices Participant has been diagnosed or suspected of hepatocellular carcinoma Participant has coinfection with human immunodeficiency virus (HIV)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Virus A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008 All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled Clinical or biochemical evidence of hepatic decompensation Advanced cirrhosis identified by large esophageal varices (F2 or F3) History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive) Excessive active alcohol consumption > 60 g/day or drug abuse Severe psychiatric disease Antiviral or corticosteroid therapy within 12 months prior to the enrollment
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Hepatitis C Adult patients of FN and metis and non-FN descent referred for treatment at the three centres will be candidates for this study
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-85.0, Inguinal Hernia Convalescence planned laparoscopic inguinal or femoral herniorrhaphy ASA class I-II speak and read danish converting to open operation low compliance (dementia, psychiatric disorder) use of morphine or similar drugs daily in the last month complications to the operation
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Every patient diagnosed with hepatitis C Patients younger than 18 years old
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Treatment naïve Age 18 and older Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months Detectable serum quantitative HCV-RNA (Cobas Taqman v2.0, Roche Diagnostics) with HCV RNA > 800,000 IU/mL HCV genotype 1 (Inno-LiPA, Innogenetics) A liver biopsy consistent with the diagnosis of chronic hepatitis C Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women) Neutropenia (neutrophil count <1,500 per cubic milliliter) Thrombocytopenia (platelet <90,000 per cubic milliliter) Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Chronic alcohol abuse (daily consumption > 20 gram per day) Decompensated liver disease (Child-Pugh class B or C) Serum creatinine level more than 1.5 times the upper limit of normal Autoimmune liver disease Neoplastic disease An organ transplant
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C HCV patients with both positive for anti-HCV and HCV RNA (Cobas Taqman, Roche Diagnostics, LOQ:25 IU/mL and LOD:10 IU/mL) Patients with signed informed consent Patients without signed informed consent HCV patients without detectable HCV RNA (Cobas Taqman, Roche Diagnostics)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Treatment naïve Age 18 and older than 18 years old Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months Detectable serum quantitative HCV-RNA (Cobas Taqman v2.0, Roche Diagnostics) Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment A liver biopsy consistent with the diagnosis of chronic hepatitis C Receive 24 or 48 weeks of PEG-IFN alfa plus ribavirin (1,000 mg/day for BW < 75 kg; 1,200 mg/day for BW ≥ 75 kg for HCV genotype 1; 800 mg/day for HCV genotype 2) Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women) Neutropenia (neutrophil count <1,500 per cubic milliliter) Thrombocytopenia (platelet <90,000 per cubic milliliter) Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Mixed HCV genotype 1 with other genotype infection Chronic alcohol abuse (daily consumption > 20 gram per day) Decompensated liver disease (Child-Pugh class B or C) Serum creatinine level more than 1.5 times the upper limit of normal Autoimmune liver disease Neoplastic disease
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic HIV Infection Ambulatory patient infected by HCV according to diagnosis used en usual clinical practice Patient no treated previously and beginning a treatment for HCV Patient that signed the informed consent to participate in the study Group A: patient with HCV monoinfection Group B: patient with HCV and HCV co-infection (according to diagnosis used en usual clinical practice) Patient that received previous treatment for HCV Patient that is going to participate in a clinical trial Turing the HCV treatment period Patient with cognitive impairment or patient unable to understand and answer the auto-administered questionnaire Patient unable to read or write Spanish
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Baseline health is stable Has a clinical diagnosis of chronic HCV infection Has a history of stroke or chronic seizures Has a history of cancer Has a history of human immunodeficiency virus (HIV) infection Has had major surgery, donated blood or participated in another investigational study within the past 3 months
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-120.0, Liver Cancer Diagnosis of hepatocellular carcinoma (HCC), as defined by 1 of the following Tissue histology Recurrence of previously resected HCC does not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator AFP > 400 ng/mL with compatible mass on MRI Locally advanced disease Not eligible for surgical resection or immediate liver transplantation OR have refused such procedures All disease must be amenable to embolization in one or two procedures Measurable disease, according to modified HCC Must have radiographically documented measurable disease with at least one site of disease that is unidimensionally measurable as ≥ 10 mm on MRI Lesions previously treated by radiofrequency ablation should not represent the only site of measurable disease
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 50.0-999.0, Osteoarthritis of the Knee primary or secondary osteoarthritis of the knee indication to TKA a mechanical axis between 20° varus and 5° valgus signed informed consent previous hemi or total arthroplasty severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 16.0-75.0, Hepatitis B, Chronic Male or female, 16 to 75 years of age 2. Compensated liver disease(Child-Pugh class A) 3. HBsAg positive at least 6 months or more 4. HBeAg positive or negative 5. Confirmation of Lamivudine-resistance HBV mutation anytime before the study 6. Patients with suboptimal response (HBV DNA > 2000 IU/mL despite combination of Adefovir [10 mg/day] plus Lamivudine [100 mg/day] for 6 months or more). Serum HBV DNA should be determined by the PCR assay at the local laboratory at screening for this study 7. Patient is ambulatory. 8. Patient is willing and able to comply with the study drug regimen and all other study requirements. 9. The patient is willing and able to provide written informed consent to participate in the study Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha fetoprotein (AFP) levels. In patients with such findings, HCC should be ruled-out prior to randomizing the patient for the present study. 2. Patient previously received oral antiviral agent other than Lamivudine or Adefovir 3. Patient has received interferon or other immunomodulatory treatment for HBV infection within 12 months before screening for this study. 4. Patient has concomitant other chronic viral infection (HCV or HIV) 5. Patient has evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dL 6. Patient has medical condition that requires use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent) 7. Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years. 8. Patient is pregnant or breastfeeding or willing to be pregnant 9. Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.). 10. A history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years. 11. Clinical signs of decompensated liver disease as indicated by any one of the following serum bilirubin > 3 mg/dL prothrombin time > 6 seconds prolonged or INR >1.6 serum albumin < 2.8 g/dL History of ascites, variceal hemorrhage, or hepatic encephalopathy Child-Pugh score ≥7
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, HIV Infections Hepatitis C Virus Between 18 and 75 years of age. 2. Ability to give informed consent. 3. Platelets greater than 70,000/mm3. 4. Hb at least 9.5 g/dl. 5. INR < 1.5 Decompensated cirrhosis. 2. Serious uncontrolled medical illness. 3. Ingestion of Aspirin within 72 hours of sigmoidoscopy 4. Ingestion of non aspirin within 8 hours of sigmoidoscopy 5. Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide. 6. Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements. 7. Alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. 8. Medical illness requiring prescribed Aspirin or NSAIDs
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Infection Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment Patients must have compensated liver disease, with no history of ascites, jaundice, hepatic encephalopathy or bleeding from esophageal or gastric varices requiring beta-blockers No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan® performed within 6 months prior to treatment which indicates the absence of liver cirrhosis, i.e., stage < F4 (METAVIR); in case of no available results, a liver biopsy will be performed prior to treatment All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed if stated non clinically significant No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg positive) No intravenous (IV) drug or alcohol abuse Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of treatment with L-thyroxin Normal electrocardiogram (ECG) Normal retinal examination (eye fundus) within last 12 months for diabetic patients or patients suffering from high blood pressure Negative pregnancy test in women of childbearing potential (a woman who is two years post-menopausal or surgically sterile is not considered to be of childbearing potential) Prior treatment for hepatitis C Malignancy within the last 5 years; except for patients with history of squamous cell skin cancer or basal cell skin cancer who will be enrolled, unless patients have a history of skin cancer at the vaccination site Diagnosed or suspected hepatocellular carcinoma History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Patients with mild to moderate depression in the past and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment Serious, concomitant medical disorder, including active systemic infection and proven or suspected immunosuppressive disorder History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogenic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia Administration of any vaccine or immunoglobulin within 30 days before the first dose of TG4040 /SOC Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled arterial or ventricular cardiac arrhythmias) Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed Any known allergy to interferon (IFN), RBV and/or their excipients
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis C Age older than 18 years old 2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test 3. Detectable serum quantitative HCV-RNA 4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA)) 5. Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin Co-infection with hepatitis B and/or human immunodeficiency virus (HIV) 2. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) 3. Decompensated liver disease (Child-Pugh class B or C) 4. Neoplastic disease within 5 years 5. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry 6. Women with ongoing pregnancy or breast feeding 7. Hgb < 11 g/dL in women or < 12 g/dL in men at screening 8. Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening 9. Serum creatinine level > 1.5 times the upper limit of normal at screening 10. Serum alpha-fetoprotein > 100 ng/mL 11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease 12. History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study 13. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease 14. History of a severe seizure disorder or current anticonvulsant use 15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) 16. Inability or unwillingness to provide informed consent or abide by the requirements of the study
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C, Chronic Liver Diseases Virus Diseases proven chronic hepatitis C aged between 18 and 65 willingness to give written informed consent to the study protocol history of having received any IFN, PEG-IFN or RBV not eligible for antiviral treatment with peginterferon and ribavirin by standard of care
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C HCV Chronic Hepatitis C Infection Hepatitis C Genotype 1 Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level greater than or equal to 100,000 IU/mL) at screening Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV Treatment naïve male or female between the ages of 18 and 65 Females must be post-menopausal for more than 2 years or surgically sterile Negative screen for drugs and alcohol Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab) No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing Be in a condition of general good health, as perceived by the investigator, other than HCV infection Significant sensitivity to any drug Use of herbal supplements within 2 weeks prior to study drug dosing History of major depression within 2 years Prior treatment with any investigational or commercially available anti-HCV agents Abnormal laboratory tests
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Virus HCV Infection Chronic HCV Hepatitis C HCV infection as documented by any licensed ELISA test kit any time prior to study entry Documentation of chronic high-titer HCV infection, as defined as a positive HCV viral load >400,000 IU/ML measured within 2 years prior to study entry and after the last interferon-based treatment course HCV genotype all genotypes are eligible for this trial Prior (but not current) treatment with interferon-based therapies are allowed Subjects with documented or suspected hepatic cirrhosis must have a Modified Child-Pugh-Turcotte (CPT) Score of 5 or less within 42 days prior to study entry Presence of known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, autoimmune hepatitis, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency Evidence of decompensated liver disease manifested by presence of or history of ascites, variceal bleeding, or hepatic encephalopathy, and/or a Child-Pugh score of 6 or higher History of major organ transplantation, including liver, with an active, functioning graft Candidates for liver transplant, as evidenced by active listing Receipt of HCV treatment within 28 days prior to study entry Breast-feeding Pregnancy, or considering getting pregnant within 1 month Use of lipid-lowering drugs (i.e. HMG-CoA reductase inhibitors, fibrates, omega-3 fatty acids, bile acid sequestrants, ezetimibe, and niacin derivatives), within 3 months prior to study entry Use of drugs with known interactions with grapefruit juice Known HIV infection
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Hepatitis C 18 years of age or older 2. on opioid substitution therapy (methadone or buprenorphine) 3. serologic evidence of chronic hepatitis C infection determined by a detectable anti-HCV antibody for 6 months or greater with evidence of detectable HCV RNA 4. elevated ALT on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing. 5. HCV treatment-naïve 6. Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection (unless contraindicated due to a bleeding disorder) 7. Compensated liver disease (Child-Pugh Grade A clinical classification). 8. All fertile males and females receiving ribavirin were required to be using two forms of effective contraception during treatment and during the 6 months after treatment 9. Women of child bearing potential were required to have a negative urine or blood pregnancy test documented within the 24-hour period prior to the first dose of study drug Women who were pregnant, breastfeeding or planning a pregnancy 2. Male partners of women who were pregnant 3. Patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug 4. Recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug 5. A positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab 6. A history or other evidence of a medical condition associated with chronic liver disease other than HCV 7. Haemoglobin <12 g/dL in women or <13 g/dL in men, a neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times the upper limit of normal at screening.) 8. A history of a severe seizure disorder or current anticonvulsant use 9. Patients with a history of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study 10. Patients with a history of thyroid disease which is poorly controlled on prescribed medications 11. Evidence of severe retinopathy 12. Evidence of excessive substance abuse as judged by the investigator 13. Patients with an increased baseline risk for anaemia (e.g. thalassaemia, spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be medically problematic. 14. Patients with a history of severe psychiatric disease (defined as acute phase of schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia, history of severe multiple episodes of self harm, currently screening as high or moderate suicide risk, current major depressive episode or current psychosis of any cause at screening)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis C Virus Infection Genotype 1 Treatment-Experienced Patients Relapses Patients aged ≥18 years old, 2. With chronic hepatitis C (CHC) infection diagnosed by seropositivity for anti-HCV antibodies or detectable HCV-RNA, at least 6 months prior to screening. 3. Patients with CHC infection of genotype 1 (1a, 1b or mixed 1a/1b) 4. Defined as relapsers: those CHC patients who had achieved virologic response (HCV-RNA non detectable) at any time during the standard care of treatment for CHC with IFN-α2 or PegIFN-α2 + ribavirin, and maintained it trough the end of treatment at week 48 weeks, but HCV-RNA detection occurs before 6 months post-treatment. 5. In whom liver cirrhosis has been ruled out through fibro-scan or liver biopsy within 24 months prior to study enrolment. 6. With a serum HCV viral load ≥ 100.000 IU/mL at screening 7. With alanine-aminotransferase (ALT) and aspartate-aminotransferase (AST) serum measurements at screening less than 5 times of their upper limits of normal (ULN) 8. With a body mass index (BMI) of at least 18 kg/m2, but not exceeding 36 kg/m2. 9. For female subjects with childbearing potential: use of a known highly effective method of birth control 10. For male subjects with partners of child bearing potential: use of appropriate contraceptive methods. 11. Is able to effectively communicate with the investigator and other testing center personnel. 12. Is able to participate and willing to give written informed consent and comply with the study restrictions (principal): 1. Hepatitis C infection of genotype 2, 3 or 4 or any mixed genotype (1/2, 1/3 and 1/4). 2. A positive ELISA for HIV-1 or HIV-2. 3. Hepatitis B virus (HBV) infection based on the presence of HBsAg. 4. Hepatitis A virus (HAV) infection based on the presence of antiHAV-IgM. (AM 4)Criteria deleted 5. Decompensated liver disease, or history of decompensated liver disease. 6. History or other evidence of a medical condition associated with decompensated renal, immunologically mediated, chronic pulmonary, cardiac, thyroid, severe retinopathy, severe psychiatric, organ transplantation, cancer, seizure disorder or pancreatitis diseases. 7. An active or suspected malignancy or history of malignancy within the last five years. 8. Patients with a documented drug and alcohol addiction free history of at least 12 months who are, in the opinion of the investigator unlikely to relapse, may be enrolled in the study. 9. Positive results for drug abuse at screening.Occasional use of cannabis previously to randomization is not an -under investigator team criteria-. The patient should be advised of abstinence during the trial (AM 6) 10. Haemoglobin <12.0g/dL for women, and <13.0g/dL for men at screening. 11. White blood cell count <2000 cells/mm3 at screening. 12. Absolute neutrophil count <1500 cells/mm3 at screening. 13. Platelet count <100.000 cells/mm3 at screening. 14. ALT and AST levels ≥ 5 xULN at screening. 15. Prothrombin time INR prolonged to 1.5xULN at screening. 16. TSH an T4 outside normal limits and not adequately controlled thyroid function at screening. 17. Poorly controlled diabetes mellitus as evidenced by HbA1c >7.5% at screening. 18. Alfa-fetoprotein value >100ng/mL at screening. 19. Total bilirubin >1.5xULN with ratio of direct/indirect >1, at screening unless predominantly conjugated and reflecting Gilbert's disease 20. Estimated creatinine clearance of 30 mL/minute or less at screening. 21. Women who are confirmed to be pregnant 22. People with known hypersensitivity to any ingredient of the investigational agents 23. Patients who are at risk of bleeding. 24. Haemoglobinopathy 25. Screening ECG QTc value ≥ 450ms and/or clinically significant ECG findings. 26. History of clinically significant drug allergies. 27. Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration. 28. Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection. 29. Requirement for chronic systemic corticosteroids. 30. Receiving systemic antivirals, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrollment
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Alcoholic Liver Disease ALD patients Excess alcohol intake Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or a suspicion of cirrhosis related to ALD Caucasian ethnicity Presence of any other chronic liver disease Co-infection with human immunodeficiency virus Controls Caucasian ethnicity Presence of a disease
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Alcoholic Liver Disease ALD patients Excess alcohol intake Abnormality of liver biopsy compatible with alcoholic aetiology Caucasian ethnicity Presence of any other chronic liver disease co-infection with HIV Controls Caucasian ethnicity presence of a disease
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-64.0, Chronic Hepatitis C Subjects who are male or females of non-childbearing potential aged 18 to 64 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2) Certain subjects must agree to use acceptable contraceptive methods as specified in protocol Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C Subjects must be in good health and have normal laboratory values as judged by investigator Subjects must not have clinically significant abnormal results for physical examination Subjects must not have received approved or experimental HCV therapy Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices Subjects must not have any known history of other cause of significant liver disease including hepatitis B, drug or alcohol-related cirrhosis, etc Subjects must not be diagnosed with or have suspected hepatocellular carcinoma Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or test capable of detecting cirrhosis within the past 2 years Subjects with a known history or other evidence of severe retinopathy or clinically significant ophthalmological disorder Subjects must not have a history of any illness that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject e.g. history of cardiovascular or central nervous system disease, ongoing psychiatric disorder, poorly controlled diabetes, etc Subject must not have taken any of the prohibited medications within the specified time before study start or take certain medications (including herbal supplements) during the study Subjects must not have a history of drug or alcohol abuse or addiction within 6 months before the start of dosing, or test positive for alcohol or drugs of abuse Subjects must not have donated or had a significant loss of blood within 56 days of the start of dosing, or donated more than 1 unit of plasma within 7 days before the start of dosing
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible) BMI greater than 25 Kg/m2 HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks Plasma HCV RNA concentration of >10,000 IU/mL at the screening evaluation Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids Women who are pregnant or breastfeeding History of diabetes mellitus requiring treatment other than diet Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol or drug-induced liver disease, or alpha-one antitrypsin deficiency Concurrent hepatitis B virus (HBV) infection Known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease Abuse of alcohol or illicit drugs within 6 months before enrollment Use of an investigational drug within 4 weeks before the screening visit or during the screening period Use of systemic immunosuppressants
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis C Viral Infection Chronic HCV genotype 1 naive patients Co infection with HBV, HIV, HDV Decompensated liver disease
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 2.0-18.0, Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic Hepatitis B DNA Virus Infections Male or female, 2 to less than 18 years of age Documented chronic hepatitis B defined by all of the following Clinical history compatible with chronic hepatitis B,Detectable serum HBsAg at the time of the study and at least one other documentation of HBsAg positive at least 6 months prior to HBeAg-positive or HBeAg-negative Serum ALT of all levels subject or subject's parent or legal guardian must be willing and able to provide written informed consent for participation in the study Patients ≥ 18 years of age Other protocol-defined inclusion/
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-60.0, Chronic HCV Hepatitis C Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count > 1500 / mm3 at screening Hemoglobin > 10 g/dL at screening Calculated creatinine clearance of > 60 cc/min at screening Normal TSH at screening HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein >20ng/ml Autoimmune Disease ANA > 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST >3x ULN, alkaline phosphatase >2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) > 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C Virus Subjects chronically infected with HCV genotype 1 Non-responder to prior therapy with peginterferon alfa and ribavirin HCV RNA viral load of 100,00 IU/mL Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma Body Mass Index (BMI) of 18 to 35 kg/m2 Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening Evidence of medical condition associated with chronic liver disease other than HCV Evidence of decompensated cirrhosis based on radiologic or biopsy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Signed written informed consent 2. Age 18 3. Presence of HCV RNA measured by quantitative PCR 4. Non responder to previous approved doses of therapy with PEGinterferon alpha plus ribavirin. Patients must have been treated for at least 12 weeks with documented HCV RNA quantitative not showing major of 2 log10 HCV RNA reduction or patients treated for at least 24 weeks with documented HCV RNA qualitative not showing a virological response (viral RNA clearance) 5. Liver biopsy consistent with a diagnosis of chronic hepatitis C or histological cirrhosis. Biopsy will not be required if the patient can produce a biopsy performed within the year preceding the randomization day and was performed at least 6 months after the end of the latter course of therapy 6. Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin 7. Negative pregnancy test prior (no more than 24 hours) to first study medication dose Use of systemic corticosteroids within 6 months of entry 2. More than one previous course of therapy with PEGinterferon alpha plus ribavirin 3. Any other liver disease 4. Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites 5. Decompensate or advanced liver cirrhosis (ChildPugh B or C) 6. HIV infection diagnosed by HIV seropositivity and confirmed by Western blot 7. Insulin-dependent Diabetes Mellitus 8. Severe haemoglobinopathy 9. Positive liver and kidney microsomal auto antibodies 10. Positive anti thyroid antibodies 11. Pregnancy as documented by a urine pregnancy test 12. Alcohol or intravenous drug abuse within the previous 1 year 13. Patients who are in poor medical or psychiatric conditions, or who have any non-malignant systemic disease that, in the opinion of the Investigator, would make it unlikely that the patient could complete the study protocol 14. Any indication that the patient would not comply with the conditions of the study protocol 15. Previous treatment with thymosin alpha 1 16. Patients with known hypersensitivity to any PEGinterferon and or ribavirin 17. Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt 18. Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry 19. Presence of serious pulmonary or cardiovascular disorders
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Liver Cancer Histologically confirmed hepatocellular carcinoma (HCC) Fibrolamellar or mixed histology allowed No cholangiocarcinoma or other tubal disease Must be eligible for conservative hepatic resection or liver resection with curative intent No cirrhosis with Child-Pugh score > 7 Chronic liver disease without liver insufficiency and without portal liver hypertension allowed No known history or presence of metastatic brain or meningeal tumors ECOG performance status 0-1 Life expectancy ≥ 3 months WBC > 3,000/µL
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-99.0, Hepatitis C HIV A subject must satisfy all of the following to be eligible to participate in this study: 1. Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded. 2. Age greater than or equal to 18 years. 3. Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL. 4. Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive. 5. Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or CD4+ cell percentage greater than or equal to 14%. 6. Ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies. 7. Participants must have a primary care physician managing medical problems. 8. For HIV infected participants, care provided by a primary physician must be consistent with the current DHHS guidelines. For those on therapy, HAART will be provided by their physician. 9. Willing to undergo genetic testing 10. About to start HCV treatment (with or without direct acting agents DAAs) A subject will be ineligible to participate in this study if any of the following are met: 1. Unable to comply with research study visits 2. Have any condition that the investigator considers a contraindication to study participation. 3. Pregnant or breastfeeding women. 4. Patients with poor venous access
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Infection HIV Infection To be eligible for participation on this protocol, a participant must satisfy all of the following conditions: Be greater than or equal to 18 years old and have an identifiable Primary Care Provider. Have either documentation of HIV-1 infection by licensed enzyme-linked immunosorbent assay (ELISA) and confirmed by a Western Blot or HIV RNA of 1,000 copies/mLor greater. Have documentation of chronic HCV (CHC) infection by demonstration of a positive test for hepatitis C antibocy and HCV RNA of 2,000 IU/mL or greater Have histopathologic features consisten with CHC at the time of enrollment. A liver biopsy done for a participant with 36 months prior to his or her participant may be used as the baseline biopsy. Participants can opt out of a biopsy if they had one or more than 36 months prior and have a contraindication, sucha as receiving chronic anticoagulation therapy. Participants with decompensated liver disease are excluded from study. Are co-infected infected with HCV genotype 1 and HIV viruses. 1. Relapsers: Participants who had an undetectable HCV RNA (< 10 IU/mL) at the end of prior treatment (ETR) but have detectable HCV RNA by Week 72 or thereafter. 2. Non-responders: Participants who have received at least 12 weeks of treatment with any IFN alfa 2a or 2b with ribavirin and have not achieved either a 2 log (10) drop in HCV viral levels at week 12 (null responder) nor has not achieved a HCV RNA below the level of detection by Week 24 (< 10 IU/mL). 3. Washout period from prior treatment of at least 3 months. Participants with CD(4) cell counts greater than or equal to 100 cells/mm(3) Capacity to understand and sign or thumbprint the Informed Consent document, as well as willingness to comply with the study requirements and clinic policies. Absolute neutrophil count > 1,000 cells/mm3. Platelets > 50,000/mm3. Hemoglobin > 10.5 mg/dL. Not pregnant or breast-feeding. Serum pregnancy test must be negative 2 weeks prior to Day -28 and to Day 0 prior to dosing with study medications for female participants. If the participant is able to become pregnant, then she must use 2 effective methods of contraception during the study. Effective contraceptive methods abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap, or sponge, or use of hormonal contraception with an anti-HIV regimen that will not alter metabolism of hormonal contraception. This is advised on the basis of using ribavirin, which may have a potential teratogenic effect on the fetus in pregnant women. NTZ had not been studied during lactation. Be willing to not become pregnant until 6 months after completion of ribavirin therapy. Male participants who are not documented to be sterile agree to either abstain from intercourse or consistently and correctly use a condom while their female partner (if applicable) agrees to use one of the appropriate medically accepted methods of birth control listed above from the date of screening until 6 months after their last dose of ribavirin. Participants with documented illicit drug use must demonstrate ability to adhere to HIV medication (with an undetectable or stable HIV viral load) and their prior primary care provider appointments (more than 80% as scheduled). Be willing to abstain from alcohol use during the trial and enter treatment program if necessary. Be able to learn to safely inject medication, be able to find another person or a clinic to inject the medication for him/her, or is willing to come to the clinic for weekly injections. Be willing to allow stored blood or tissue samples to be used in the future A participant will be ineligible to participate on this study if any of the following are met: A participant cannot be on other experimental therapies (including expanded access/compassionate use of antiretrovirals) for 28 days prior to Day -28 and during his/her participation in this protocol. Mixed genotypes (e.g., 1 & 2, 1 & 3,1 & 4). Mixed genotype 1a/1b will be enrolled. Has any other known, or clinically suspected, cause of liver disease, including active hepatitis B. For participants with cirrhosis, a Child Turcotte Pugh score > 7, or Child's B or C cirrhosis. Has a prothrombin time International Normalized Ratio (PT-INR) > 2 and is not on chronic anti-coagulation medications, or has a history of hemophilia. Has had an organ transplantation other than cornea or hair. Has an estimated creatinine clearance (estimated glomerular flow rate) < 50 mL/min. For a participant with higher than 20 ng/mL of alpha-fetoprotein, a negative ultrasound or computerized tomography scan to rule out hepatoma is required for enrollment. Has any neoplastic disease for (1) Kaposi's sarcoma not requiring systemic chemotherapy, (2) any non-metastatic skin cancer that has been resected or (3) non-metastatic cervical or anal cancer that has been resected. Has evidence of severe cardiac disease (greater than or equal to Grade 3 congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, or uncontrolled hypertension) despite intervention or medical therapy. Has evidence of severe chronic pulmonary disease with functional impairment or a DLCO (diffusing capacity of the lung for carbon monoxide) less than or equal to 70% at baseline. Has a severe psychiatric disorder that would interfere with the adherence to protocol requirements, and that is not stably treated with risk of decompensation. Has evidence of autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis. Has evidence of an uncontrolled seizure disorder defined as more than 1 episode of generalized seizure within the past year. Has chronic pancreatitis. Has severe retinopathy, as determined by the ophthalmologist. Has any hemoglobinopathy (e.g., Thalassemia, sickle cell disease). Is currently taking didanosine or d4T as part of antiretroviral regimen. If total bilirubin is greater than 1.5 mg/dL then direct bilirubin can be no more than 70% of the total, up to a direct bilirubin of 2.0 mg/dL. Concurrent use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of > 10 mg/day) for a duration of 6 weeks or more within 6 months prior to enrollment. Inhaled steroids will be allowed, even with ritonavir. Has active systemic infections other than HCV and HIV. Has a hepatic mass suggestive of hepatocellular carcinoma as detected by ultrasound scan, dual-phase computerized tomography, or magnetic resonance imaging. Has evidence of moderate or heavy alcohol use (> 50 grams/day), or substance abuse, within the past 6 months that potentially could interfere with participant compliance. (Urine toxicology will be completed at screening.) Currently uses warfarin, ganciclovir, isoniazid, pyrazinamide, rifabutin, rifampin/rifampicin, thalidomide, or theophylline. Has a history of esophageal or gastric varices. Has any systemic illness that will make it unlikely that the participant will be able to return for the required study visits. Has evidence of gastrointestinal malabsorption, chronic nausea, or vomiting. The participant is the male partner of a pregnant woman and does not always use a condom during intercourse. Women who are pregnant. Women who are breast-feeding. Has a hypersensitivity to NTZ, interferon products, or ribavirin. Has ingested silymarin (milk thistle), s-adenosylmethionine (SAM-e), glycyrrhizin, Sho-saiko-to (SST), or other herbal supplements that may be either liver beneficial or toxic, within 28 days prior to Day -28
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C Virus Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening HCV RNA ≥ 10*5* IU/mL at Screening Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening Liver transplant recipients Documented or suspected HCC by imaging or liver biopsy Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive) Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Virus Chronic Liver Disease Viral Hepatitis Therapeutic Uses Antiviral Agents Naive adult subject active HCV infection (HCV-RNA positive) histological/biochemical signs of chronic hepatitis or compensated cirrhosis willingness of treatment autoimmune disorders severe depression or psychiatric disease previous decompensation of cirrhosis gastroesophageal bleeding hepatocellular carcinoma major disease with a life expectancy of less than 5 years pregnancy or nursing
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Liver Fibrosis chronic hepatitis C chronic hepatitis B alcoholic liver disease non alcoholic steatohepatitis ascitis
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Liver Failure was diagnosed according to the from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000 age >18 years HBV DNA > 3log10 copy/mL Pregnant or lactating women Diagnosed or suspected as hepatic carcinoma patients Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment A history of drug abuse or alcohol abuse Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs A history of using immunomodulator including steroids Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C, Chronic Adult patients, 18-65 years of age Chronic hepatitis C, genotype 2 or 3 Positive HCV RNA level in serum at screening (COBAS HCV test) Abdominal sonography within 3 months prior to study start Previous interferon and/or pegylated interferon and ribavirin therapy Liver cirrhosis, class B or C (Child-Pugh) Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C Decompensated liver disease Positive for HIV
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Male or female between the ages of 18 and 65 years 2. Chronic hepatitis C virus (HCV) genotype 1 infection 3. HCV RNA level >10,000 IU/mL 4. Chronic HCV infection, defined as Previous documentation of positive HCV serology (HCV antibody or RNA) at least 6 months (24 weeks) previously, or Positive HCV serology (HCV antibody or RNA) with a prior remote (more than 6 months previously) risk factor for acquisition of HCV or Historical biopsy consistent with chronic HCV infection 5. No clinically significant abnormalities in hematology, coagulation, or chemistry variables Hemoglobin >12 g/dL for women; >13 g/dL for men Total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3 Platelets >100,000/mm3 Prothrombin time (PT) and/or international normalized ratio (INR) less than or equal to 1.2 times the local upper limit of normal (ULN) Conjugated (direct) bilirubin less than or equal to 1.5 times the ULN Serum creatinine within normal limits Previous interferon-based antiviral therapy for chronic HCV infection 2. Previous treatment with known immunogenic drugs 3. Concomitant human immunodeficiency (HIV) or hepatitis B virus (HBV) infection 4. Cause of liver disease other than chronic HCV infection, such as autoimmune or alcoholic liver disease 5. Decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites 6. Recipient of liver or other solid-organ transplantation 7. Evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding 8. History of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia) 9. History of thromboembolic events (eg, deep-vein thrombosis [DVT] or pulmonary embolism). Previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment. 10. Requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins) 11. Condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids 12. Investigational therapy within 28 days before the first planned dose of study drug 13. Major surgery within 28 days before the first planned dose of study drug 14. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease) 15. Ongoing angina pectoris or other symptoms of coronary artery disease (CAD); history of stroke, or transient ischemic attack (TIA) 16. History of suicidal ideation or attempt 17. Condition requiring treatment (past or current) with coumarin-type agents 18. Cardiac arrhythmia requiring medical therapy 19. Serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture) 20. Cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an AE) 21. Female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-80.0, Varices The etiology of portal hypertension is cirrhosis. 2. Age ranges between 20-80 y/o. 3. Patients presenting with acute gastroesophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: 1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or 2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding). Gastric variceal bleeding is defined as active spurting from a gastric varix or presence of red spots on a gastric varix. 4. EVL is performed after confirmation of acute esophageal variceal bleeding. Histoacryl injection is performed if acute gastric variceal bleeding is diagnosed. Bleeding is arrested on the spot association with severe systemic illness, such as sepsis, COPD, uremia, HCC, > BCLC stage B 2. failure in the control of bleeding by emergency endoscopic treatment. 3. moribund patients, died within 12 hours of enrollment 4. Uncooperative 5. Ever received EIS, EVL within one month prior to index bleeding 6. Child-Pugh's scores > 13 7. Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Acute Hepatitis C HIV Documented current or past acute hepatitis C infection with detectable HCV-RNA (PCR-assay) with an estimated duration of 52 weeks at diagnosis as defined below First HCV RNA positive AND Prior negative anti-HCV antibody or HCV RNA test within 12 months OR Rise of liver transaminases above 2.5 x upper limit of normal (ULN) within the past 12 months with prior normal transaminases during the year before AND of other causes of acute hepatitis Acute liver disease other than hepatitis C Inability to provide written informed consent Younger than 18 years of age
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hepatitis C confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting The pregnant patients patients with side effect which confirmed with rechallenge test
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to: 1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or, 2. liver biopsy consistent with chronic HCV infection. 2. HCV genotype 1 infection confirmed by genotypic testing at screening. 3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection. 4. HCV RNA = 1,000 IU/mL at screening 5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit. Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not patients from a trial. 6. Age 18 to 70 years 7. Female patients: (c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device. Male patients: 1. who are documented to be sterile, or 2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. 8. Signed informed consent form prior to trial participation HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. 3. HIV co-infection. 4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag. 5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months 7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study. 8. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study. 9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened. 10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase. 11. Known hypersensitivity to any ingredient of the study drugs. 12. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2). 13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following: 1. International normalized ratio (INR) of =1.7 2. Serum Albumin =3.5 g/dL 3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome). 14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C A subject will be eligible for in this study only if all of the following apply: Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (i.e., ECG), including no cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years Males or females between 18 and 65 years of age inclusive, at the time of signing the informed consent A female subject is eligible to participate if she is of non-childbearing potential Body weight > or = 50 kg (110 lbs.) for men and > or = 45 kg (99 lbs.) for women and BMI between 18.5-35.0 kg/m2 inclusive will be allowed Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form AST, ALT, and alkaline phosphatase <3.0xULN and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Average QTcB or QTcF < 450 msec; or QTcB or QTcF < 480 msec in subjects with Bundle Branch Block Treatment naive chronically infected HCV subjects, defined as infection for >6 months and no prior HCV therapy, with an HCV RNA viral load of greater than 100,000 IU/mL and HCV genotype 1a or 1b. HCV subjects with mixed genotypes are not eligible for the study Positive for HCV RNA and anti-HCV antibody at the time of screening AND positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening; OR Positive for HCV RNA and anti-HCV antibody at the time of screening AND liver biopsy within three years prior to screening indicating the absence of cirrhosis Unwillingness or inability to follow the procedures outlined in the protocol Subject is mentally or legally incapacitated A positive pre-study Hepatitis B surface antigen or HIV antibody within 3 months of screening A positive pre-study drug/alcohol screen History of regular alcohol consumption within 6 months of the study Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). Exposure to more than four new investigational products within 12 months prior to the first dosing day Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 16.0-999.0, Acute Hepatitis C Male and female patients ≥ 16 years of age Recent hepatitis C infection with an estimated duration of Infection ≤ 18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable and Adequate English to provide written, informed consent and to provide reliable responses to the study interview Provision of written, informed consent All patients: • Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples Treatment group only Age between 16 and 18 years Women with ongoing pregnancy or breast feeding Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug Any investigational drug <6 weeks prior to the first dose of study drug Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening Serum creatinine level >1.5 times the upper limit of normal at screening
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Metabolic Syndrome Aged 18 y/o or older 2. Positive for the HCV antibody and HCV RNA detected 3. Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis 4. Have not been previously treated with pegylated-interferon and ribavirin for HCV 5. Genotype 1 or Genotype 2 Subjects with decompensated liver disease 2. With human immunodeficiency virus 3. With hepatitis B infection 4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants 5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases 6. Subjects who are on lipid-lowering medications 7. Poorly controlled Diabetes (A1C > 9%) -
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Chronic Hepatitis B Chronic Hepatitis C Male or female and at least 20 years of age Chronic hepatitis B or Chronic hepatitis C Evidence or history of hepatocellular carcinoma History of alcohol abuse (alcohol intake > 20g/day) Pregnant or lactating patients Psychosis
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic years of age chronic HCV infection HCV genotype 2/3 infection active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy compensated liver disease negative pregnancy test (within 24 hours of first dose of study medication) effective contraception for the duration of the study written informed consent previous interferon or ribavirin therapy investigation drug use in the 6 weeks prior to first dose of study medication infection with HCV genotypes other than 2/3 HIV infection HBV infection ongoing severe psychiatric disease frequent drug use that is judged by the treating physician to compromise treatment safety standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Lymphoma Neuroblastoma Rhabdomyosarcoma Patients with acute/chronic leukemia, myelodysplastic syndrome, lymphoid neoplasia, solid tumor or bone marrow failure syndrome signed informed consent of the patient (or his/her legal representative) Patients with graft failure Patients with any grade of active acute of chronic graft-versus-host disease (GvHD)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C Virus Documented chronic (> 6 months) genotype 1a or 1b Hepatitis C virus (HCV) infection Treatment-naive volunteer, meaning never received (Peg)IFN, RBV or any other approved or investigational treatment for chronic HCV infection (Panels 1, 2, 3 or 4) OR volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (IFN/RBV or pegylated IFN/RBV) but has stopped this treatment at least 6 months before screening volunteer has never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year (Panels 1, 2 or 3) Volunteer with HCV plasma RNA levels of > 100,000 IU/mL at screening Body Mass Index of 18.0 to 35.0 kg/m2 Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram Evidence of liver cirrhosis Historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (Fibroscan) result of more than 14.6 kPa within 2 years prior to screening Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices Evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 mL/min Evidence of any other cause of significant liver disease in addition to hepatitis C, this may but is not limited to hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis Volunteer with diagnosed or suspected hepatocellular carcinoma Volunteer receiving or having received any treatment for HCV during the 6 months before screening Volunteer coinfected with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2, or hepatitis A or B virus infection, or clinically active tuberculosis at study screening
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Chronic Hepatitis C All women treated for HCV chronic hepatitis, at the Unit Gastroenterology, University of Modena and Reggio Emilia, in the last 7 years Control group is a cohort matched for age (ratio 1:1) selected from a group of 558 men with chronic HCV treated in the same period aret pre-defined as the study includes all patients who were treated for chronic HCV hepatitis; was made upstream of the constitution of this cohort
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Subjects must meet all of the following to be eligible for participation in this study Male or female, aged from 18 to 70 years old, inclusive Willing and able to provide written informed consent Chronic HCV infection for at least 6 month prior to baseline (Day 1) in subjects currently positive for HCV-RNA and anti-HCV antibody documented by A positive anti-HCV antibody test, positive HCV-RNA assay, or HCV genotype test at least 6 month prior to baseline (Day 1) or A liver biopsy performed prior to baseline (Day 1) with evidence of chronic HCV infection Subjects must have liver biopsy results (performed no more than two years prior the screening) indicating the absence of cirrhosis HCV infection limited to genotype 1 Detectable plasma HCV-RNA at screening BMI between 18 and 36 Kg/m2 Pregnant women or women who may wish to become pregnant during the course of the study Male with a female who is pregnant or is planning to become pregnant within seven month the study of anticipated last dose of ribavirin Evidence of infection or co-infection with a no-genotype 1 HCV-strain History of hemoglobinopathy History of sarcoidosis History of invasive malignancy diagnosed or treated within 5 years Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, history of a suicide attempt Co-infection with HBV or HIV Chronic use of systemic immunosuppressive agents Presence of autoimmune disorders; subjects with treated hypothyroidism with normal TSH may be enrolled
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-70.0, Hepatitis C, Chronic Japanese participant diagnosed with compensated CHC GT 1 Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (partial responder or null responder) No evidence of cirrhosis Co-infection with human immunodeficiency virus (HIV) Positive hepatitis B surface antigen or other evidence of active hepatitis B infection Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Hepatitis C For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Amendment 4: Genotype 1, 10 subjects at site 401 Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2 Diagnosed with chronic HCV at least 6 months prior to Visit 1 with medical documentation (e.g., prior PCR result, prior liver biopsy, prior genotyping, etc.), with a positive HCV viral load of at least 50,000 IU/mL at Visit 1 (screening) as measured by quantitative PCR Chronic genotype 2 or 3 HCV infection (per polymerase chain reaction [PCR] methodology) HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with IFN alfa 2a or 2b, Pegylated IFN alfa-2a, Ribavirin, or any HCV direct-acting anti-viral drugs Liver biopsy consistent with chronic HCV infection but with a classification of non-cirrhotic (and without classification of 'transition to cirrhosis or borderline cirrhosis') as judged by a pathologist (defined as Knodell ≤ 3, Metavir ≤ 2, Ishak ≤ 4, or Batts &Ludwig ≤ 2 ) within the last two years and before Visit 2 (biopsy can be done after Visit 1 and before Visit 2, within the screening period) Negative urine drug screen for drugs of abuse and methadone (via central lab-provided dipstick at site) at screening (Visit 1) (note: subjects with a valid prescription for a drug which can be abused [e.g., benzodiazepine, opiates] can be enrolled on the judgment of the investigator) Females will have a negative serum beta human chorionic gonadotropin (βHCG) pregnancy test at screening and a negative urine dipstick pregnancy test on Study Day 0 (visit 2) Agreement by both female subjects of childbearing potential and male subjects (who have not been surgically sterilized) to practice an acceptable method of birth control, which includes at least one barrier during the study and for at least 6 months after the cessation of treatment. Surgical sterilization of either the female or the male partner must have occurred at least 6 months prior to the first dose and females must be post-menopausal for 2 years to be considered of non-child-bearing potential. Acceptable contraceptive methods one of the following: Oral and implantable hormonal contraceptives by the female partner for at least 3 months prior to the first dose of Study Drug with additional use of a barrier method, IUD in place for at least 6 months prior to first dose with additional use of barrier method. Acceptable barrier methods either diaphragm with spermicide, and condom with spermicide. (Note: Abstinence is not an acceptable method of birth control, subjects who indicate sexual inactivity must agree to utilize an acceptable method of birth control in the event of sexual activity) Willing and able to complete all study visits and procedures, and able to effectively communicate with the investigator and other testing center personnel Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin > 2, Alanine transaminase (ALT) or Aspartate aminotransferase (AST) laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease, or hepatocellular carcinoma Chronic liver disease other than HCV not limited to Hepatitis B virus (HBV) [positive test for hepatitis B surface antigen (HBsAg)], hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease History of liver transplantation Co-infection with Human immunodeficiency virus (HIV) [positive test for anti-HIV Ab] or use of didanosine History of a heart attack, cardiac ischemia, heart disease, clinically symptomatic cardiac abnormalities, or blood clots, based on medical history or apparent on physical exam QTcF interval at Visit 1 of greater than or equal to 450 ms by Fridericia's correction, or a personal or family history of Torsades de Pointe History or presence of sarcoidosis or pancreatitis History or presence of severe pulmonary function impairment including severe (> GOLD stage III) chronic obstructive pulmonary obstructive disease, and moderate to severe asthma Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening (Visit 1) Use of the following medications concurrently or within the 30 days prior to Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants (specifically excluded medication will be listed in protocol Section 6.8)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Liver Disease Patients with chronic HCV infection irrespective of HCV genotype HCV infected patients previously treated with antiviral drugs; co-infected Patients with HIV or Hepatitis B virus (HBsAg positive)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis HIV/AIDS To be eligible for participation on this protocol, a participant must satisfy all of the following conditions: 1. Be greater than or equal to18 years old and have an identifiable primary care provider. 2. Have documented chronic HCV infection by demonstration of a positive test for hepatitis C antibody and HCV RNA of 2,000 IU/mL or greater. 3. Infected with HCV GT-1 virus. 4. If coinfected, have either documentation of HIV-1 infection by licensed enzyme-linked immunosorbent assay (ELISA) confirmed by a Western Blot or history of HIV RNA of 1,000 copies/mL or greater. 5. If coinfected, must meet one of the following prior to enrollment: 1. If on a stable non-NNRTI or non-PI antiretroviral regimen that HAS NOT changed within the past 6 months, must have an HIV-1 VL of less than 400 copies/mL for at least 3 months; or 2. If on a current antiretroviral regimen that HAS changed within the past 6 months, have an HIV-1 VL of less than 50 copies/mL for at least 3 months; or 3. Be a long-term nonprogressor as documented in the medica record. 6. Have histopathologic features consistent with chronic HCV infection at the time of enrollment. A liver biopsy within 3 years (36 calendar months) prior to screening may be used as the baseline biopsy. Participants can opt out of a liver biopsy if they had one more than 3 years prior and have a contraindication, such as receipt of chronic anticoagulation therapy. Participants with decompensated liver disease are excluded from the study. 7. Are na(SqrRoot) ve to prior IFN-based treatment for HCV. 8. Have CD4 cell counts greater than or equal to 100 cells/mm(3). 9. Willing to have genetic testing. 10. Not pregnant or breastfeeding. Serum pregnancy test must be negative at screening for female participants. 11. Agree not to become pregnant if a female of childbearing potential while on the study and for at least 6 months after stopping RBV. Because of the potential teratogenic effects of RBV treatment, subjects and their partners must remain abstinent or use two methods of birth control, which may be selected from the following list (oral contraceptive concentrations are decreased, and may not be effective when used during BOC treatment and, therefore, are not included in this list): Surgical sterilization of either partner Intrauterine device Male or female condoms with or without a spermicide Diaphragm, cervical cap, or sponge 12. Male participants who are not documented to be sterile must agree to either abstain from intercourse or consistently use a condom while their female partner (if applicable) agrees to use one of the appropriate medically accepted methods of birth control listed above from the date of screening until 6 months after the last dose of RBV. 13. Be able and willing to either learn to safely inject medication or find another person to inject the medication for him/her. 14. Be willing to allow storage of blood or tissue samples for future research. Co-enrollment Guidelines: Participants may be enrolled in other NIH protocols as long as the amount of research blood drawn does not exceed the acceptable NIH guidelines and the protocol does not other experimental therapies (including expanded access/compassionate use of HIV antiretrovirals) A participant will be ineligible to participate on this study if any of the following are met: 1. Use of other experimental therapies (including expanded access/compassionate use of HIV antiretrovirals) within 30 days or 5 half-lives (whichever is longer), prior to enrollment. 2. Current use of an efavirenz-based (or other NNRTI) or protease inhibitor HIV antiretroviral regimen. 3. Use of any of the following medications within 6 weeks prior to enrollment. Alfuzosin (Uroxatral ) Alprazolam (Xanax ) Atorvastatin (Lipitor ) AZT or zidovudine (Retrovir ) Carbamazepine (Tegretol ) Cisapride (Propulsid ) Colchicine (Colcrys ) If patient has renal or hepatic impairment. DDI or didanosine (Videx ) d4T or stavudine (Zerit ) Delaviridine (Rescriptor ) Digoxin (Lanoxin ) Dihydroergotamine Drosperinone (Yaz ) Efavirenz (Sustiva ) Ergonovine (Ergotrate ) Ergotamine (Cafergot ) Etravirine (Intelence ) Ganciclovir (Cytovene ) Immunosuppressive therapy (including oral steroids) ---Use of any use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of greater than 10 mg/day) for a duration of 6 weeks or more within 6 months prior to enrollment. Use of inhaled/nasal steroids should be avoided. Isoniazid or INH (Ingredient in Rifater ) Ketoconazole (Nizoral ) Lovastatin (Mevacor ) Methylergonovine (Methergine ) Midazolam given orally (Versed ) Nevirapine (Viramune ) Phenobarbital (Luminal ) Phenytoin (Dilantin ) Pimozide (Orap ) Pyrazinamide (Ingredient in Rifater ) Rifabutin (Mycobutin ) Rifampin/rifampicin Rilpivirine (Edurant ) Sildenafil (Viagra ) Phosphodiesterase type 5 inhibitors are prohibited when used for pulmonary hypertension Simvistatin (Zocor ) St. Johns s Wort Tadalafil (Cialis ) Phosphodiesterase type 5 inhibitors are prohibited when used for pulmonary hypertension Thalidomide (Thalomid ) Theophylline (Slo-Phylllin ) Triazolam (Halcion ) Vardenafil (Levitra ) Phosphodiesterase type 5 inhibitors are prohibited when used for pulmonary hypertension Warfarin (Coumadin ) Zalcitabine (Hivid ) There may be other brand names for these products listed above. 4. Has ingested silymarin (milk thistle), s-adenosylmethionine (SAM-e), glycyrrhizin, Sho-saiko-to (SST), or other herbal supplements that may be either liver beneficial or toxic, within 28 days prior to enrollment. 5. Mixed HCV genotypes (e.g., 1 & 2, 1 & 3, 1 & 4) (mixed genotype 1a/1b can be included). 6. Has any other known, or clinically suspected, cause of liver disease, including active hepatitis B. 7. For participants with cirrhosis, a Child Turcotte Pugh score greater than 7, or Child s B or C cirrhosis. 8. Certain abnormal hematological and biochemical parameters, including: 1. Neutrophil count less than1000 cells/mm3 2. Hemoglobin less than10g/dL 3. Platelet count less than or equal to 50,000 cells/mm3 4. Estimated glomerular filtration rate less than50 mL/min/1.73 m(2), calculated automatically by the NIH lab using the original MDRD (modification of diet in renal disease) study equation 5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than or equal to10 time ULN 6. Prothrombin time International Normalized Ratio (PT-INR) less than2 and/or on chronic anticoagulation medications 7. If total bilirubin is greater than 1.5 mg/dL, then direct bilirubin can be no more than 70% of the total, up to a direct bilirubin of 2.0 mg/dL. 9. Alpha-fetoprotein less than20 ng/mL, unless an ultrasound, computerized tomography scan (CT), or magnetic resonance imaging (MRI) has been performed to rule out hepatoma. 10. Hepatic mass suggestive of hepatocellular carcinoma as detected by ultrasound scan, dual-phase CT, or MRI. 11. History of esophageal or gastric varices. 12. Any neoplastic disease or any nonmetastatic skin, cervical, or anal cancer that has been resected in the past 5 years Kaposi s sarcoma not requiring systemic chemotherapy. 13. Prior organ transplantation other than cornea or hair. 14. Evidence of severe cardiac disease (greater than or equal to Grade 3 congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, or uncontrolled hypertension) despite intervention or medical therapy. 15. Evidence of severe chronic pulmonary disease with functional impairment. 16. Severe psychiatric disorder that would interfere with adherence to protocol requirements, and that is not stably treated. 17. Evidence of autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis. 18. Evidence of an uncontrolled seizure disorder defined as more than 1 episode of generalized seizure within the past year. 19. Chronic pancreatitis based on clinical history. 20. History of severe retinopathy. 21. History of hemophilia. 22. Any hemoglobinopathy (e.g., Thalassemia, sickle cell disease). 23. Active systemic infections other than HCV and HIV-1. 24. Evidence of gastrointestinal malabsorption, chronic nausea, or vomiting. 25. Has any systemic illness that will make it unlikely that the participant will be able to return for the required study visits. 26. Any condition that, in the opinion of the investigator, contraindicates participation in this protocol. of Children: Because there are insufficient data regarding the safety and efficacy of BOC, PEG, or RBV in the pediatric population, children are excluded from this study. of Women: Pregnancy: Pregnant women are excluded from this study because the effects of BOC, PEG, and RBV on the developing human fetus are unknown. Preclinical animal data indicate that the use of RBV treatment during pregnancy is potentially teratogenic. Breastfeeding: Because there is an unknown but potential risk for adverse effects in nursing infants secondary to treatment of the mother with BOC, PEG, or RBV, breastfeeding women are excluded from this study
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Participants chronically infected with HCV Genotype 4 HCV RNA viral load of ≥ 10,000 IU/mL No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted Evidence of decompensated liver disease Documented or suspected Hepatocellular carcinoma (HCC) Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis C Infection Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay Antiherpes or immunomodulatory therapy during the past 30 days HIV or chronic hepatitis B infection Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus) Creatinine clearance < 50 ml/min Female subject who is pregnant or nursing Gastrointestinal disorder which might result in malabsorption of valacyclovir History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome Therapy for hepatitis C in the previous 6 months
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis C Men and women, ages ≥18 years of age Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment Subjects should have chronic hepatitis C (CHC) as documented by: 1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or 2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis) HCV genotype 1a, 1b or 4 only HCV RNA viral load of ≥10,000 IU/mL at screening Have one of the following: 1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR 2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR 3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures) History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment Documented or suspected hepatocellular carcinoma (HCC) Positive for hepatitis B surface antigen (HBsAg) Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN) Total Bilirubin ≥2 mg/dL
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C, Chronic Male and female subjects, 18 to 70 years of age, inclusive Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration Subjects have IL28B CC genotype determined during screening Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment Subjects have evidence of hepatic decompensation Subjects have evidence of cirrhosis Subjects have diagnosed or suspected hepatocellular carcinoma Subjects have any other cause of significant liver disease in addition to hepatitis C, which may but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Acute Viral Conjunctivitis Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle
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0
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