topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-70.0, In This Prospective Randomized Study, the Efficacy of Four-quadrant and Two-quadrant Laparoscopic-assisted Transversus Block Will be Invastigated American Society Anesthesia (ASA) 1 and 2 patients aged 18-70 years Patients who did not agree to participate in the study, 2. ASA 3 and above patients, those who will undergone emergency surgery, open cholecystectomy 3. BMI of >40, 4. İntraoperative major complications, 5. History of severe allergy, 6. Chronic analgesic use
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 4.0-7.0, Pulp Disease, Dental Medically free children who will be able and cooperative in all steps of the study. 2 Asymptomatic primary molars with a deep carious lesion. 3 Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment. 3 Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction. 4 Absence of pre-operative pain or they will only have a short-term pain. 5 No tenderness to percussion. 6-Age ranging 4-6 years Excessive bleeding during pulp amputation. 2 Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space. 6 Parent or guardians who refuse participating in the study
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Irritable Bowel Syndrome Functional Dyspepsia Subject has read and signed the institutional review board-approved informed consent form before screening. 2. ≥18 years old. 3. Confirmed irritable bowel syndrome (ibs) or functional dyspepsia (fd) diagnosis per rome iv criteria. 4. Has active symptoms of bloating. 5. Subject must be willing to comply with the protocol. 6. Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study*. *women of childbearing potential must have a negative pregnancy test prior to randomization into the study and commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, hormonal contraception, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study. based on ich, m3 (r2) 2009 a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. permanent sterilization methods tubal ligation, hysterectomy, bilateral oophorectomy Presence of any organic gastrointestinal diseases. 2. Subjects with known hypersensitivity to Iberogast or one of the active substances or excipients. 3. One or more medical condition(s), including renal, hepatic, hematologic, endocrinological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this study. 4. Subjects with impaired liver function tests 5. Malignant disease not in remission. 6. Presence of any active infectious disease. 7. Subjects not willing to stop medications that may interfere with gastrointestinal motility during 48 h previous to the gas infusion tests. These bulking agents, laxatives, linaclotide, prokinetics, antidiarrheal or opioids. 8. Known alcohol or drug abuse. 9. Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception. 10. Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 19.0-70.0, Gallstone; Colic trainees in general surgery 2. No experience of laparoscopic cholecystectomy 3. Less than 5 experiences of laparoscopic surgery 4. Uncomplicated symptomatic gallstone disease Experience with laparoscopic cholecystectomy. 2. More than 5 experiences of laparoscopic surgery
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 19.0-70.0, Cholecystitis, Acute among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II) 2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging 3. Gallbladder with surrounding organs due to gallbladder inflammation 4. Patients over 19 years of age, under 70 years of age patients with elective gallbladder surgery (chronic cholecystitis) 2. gallbladder disease not inflammatory disease (GB cancer, GB polyp) 3. pregnant women, patients under 18 years of age, over 70 years of age 4. patients with simultaneous surgery due to other organ diseases 5. immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients 6. patients with hemorrhagic tendency, or with hematologic diseases 7. Patients who underwent percutaneous cholecystectomy (PTGBD)
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 or chronic thromboembolic pulmonary hypertension, group 4 Invasive of pulmonary hypertension Age ≥ 18 years Signed informed consent planned right heart catheterization based on clinical grounds Other etiologic groups of pulmonary hypertension (WHO group 2, 3, 5) Patients with congenital heart disease Atrial septal defects Clinical relevant left heart disease Atrial fibrillation / Atrial flutter Ablations of the right atrium History of major cardiac surgery Atrial occlude Metallic implants Pacemakers
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-85.0, Cholecystitis/Cholelithiasis Cholecystitis; Gallstone Polyp Gallbladder Aged 18-85; 2. Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases; 3. Older patient or accompanied by cardiopulmonary diseases (age>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al); 4. Aged older than 60, with or without the above diseases; 5. American society of Aneshesiologists (ASA) II or higher; 6. Informed consent acquired Having contraindication of laparoscopic operations; 2. History at epigastric surgery. -
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Gall Stones (& [Calculus - Gall Bladder]) Surgery Must be above 18 years of age Liver Cirrhosis Hepatobiliary and pancreatic malignancy
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-65.0, Acute Gastroenteritis Abdominal Pain Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain Peritonitis Hemodynamic instability Pregnancy Inability to give consent Medication given in the emergency room before being included in the study Taking pain medication within 4 hours Diabetes Mellitus and other neuropathic diseases
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 2.0-17.0, Appendicitis Diagnoses Disease Pediatric ALL all children referred with abdominal pain from January 2000 to June 2006 to one surgeon on the pediatric general surgery service at the Health Sciences Centre (HSC)-Children's Hospital in Winnipeg children with abdominal pain > 7 days children with abdominal pain due to other surgical or medical conditions
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-65.0, Laparoscopic Cholecystectomy Cholelithiasis Postoperative Analgesia Patients undergoing elective laparoscopic cholecystectomy for cholelithiasis ASA (American Society of Anesthesiologists) I-II Patient refusal Perforation of the gallbladder Patients with acute cholecystitis History of the previous gallbladder surgery Pregnancy Morbid obesity Psychiatric disorder Epilepsia Renal insufficiency Coagulopathy
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Anesthesia, Spinal Nonemergency Cesarean Section Age ≥ 18 years old Affiliation to social security system Scheduled or elective Caesarean section (green code) under spinal anesthesia Refusal to participate in the study Code red Caesarean section or general anesthesia decision Complicated" Caesarean section or combined spinal-epidural technique Presence of an epidural catheter Performing a combined spinal-epidural technique (even if the epidural catheter is not used) Contraindication to spinal anaesthesia (coagulation disorder, vertebral-medullary pathologies) Patient under guardianship or curatorship
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-70.0, Diverticular Disease of Left Side of Colon Patient who has received informed information and has not expressed opposition to participation Francophone patient Patient affiliated to a social security or equivalent system Patient taken in charge for smoldering DS after DS Hinchey I persistence of symptoms after DS complicated by a peri-sigmoid abscess <1cm with resolution of inflammation DS complicated with an abscess >1cm (Hinchey II) Recurrent episodes of DS DS in a patient requiring long-term immunosuppressive therapy (except for neoplastic disease undergoing treatment) Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis (surgical experimental group) or patient not operated and medically treated (medical control group) Subjects meeting only one of the following non-inclusion may not be eligible to participate in the research Patient who is a minor or over 70 years of age Patient undergoing emergency surgery for sigmoid diverticulitis due to a complication (peritonitis, hemorrhage, failure of drainage diverticular abscess) diverticulitis complicated by fistula and/or symptomatic stenosis Colorectal resection protected by an ostomy or Hartmann's intervention Discovery of colorectal cancer on the operating room Patient operated on for diverticulitis of the right colon Neoplastic disease under treatment and/or evolving
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-85.0, Anesthesia Cancer Age between 18 and 85 years-old The American Society of Anesthesiologists (ASA) physical status classification from I to III To be submitted to Spinal Anesthesia For surgeries performed by the Bone and Connective Tissue (TOC) service Involving lower limbs and inguinal region requiring sensory block level up to the T12 dermatome (except for larger amputations and bone resections) Expected duration of less than 120 minutes In supine position That they voluntarily decide to participate in the study Coagulation disorder that prevents the execution of the blockade International normalized ratio for prothrombin (INR) time and activity > 1.5 Activated partial thromboplastin time ratio (PTTa) >1.5 Use of enoxaparin up to 40mg/day less than 12h before the procedure Use of enoxaparin above 40mg/day less than 24hours before the procedure Use of oral anticoagulant or platelet aggregation inhibitors in a lower interval than recommended for spinal block Other coagulation disorders that prevent spinal anesthesia Moderate or severe left ventricular systolic dysfunction (defined by the presence of left ventricle ejection fraction below 40%) Sinus bradycardia (FC < 50 beats per minute) Relevant cardiac conduction system disorders (e.g. atrium ventricular block greater than first-degree, Wolf-Parkinson-White syndrome)
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-75.0, Acute Pancreatitis Chronic Pancreatitis ALL All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes ALL Meet one set of group-specific listed below ALL All participants must be >= 18 years old and =< 75 years at the time of enrollment NO No personal history or symptoms of pancreatic disease NO No upper abdominal symptoms NO No family history of pancreatic disorders, celiac disease, cystic fibrosis NO No history of acute infectious or inflammatory conditions requiring medical treatment or evaluation in the preceding 6 months (per provider clinical judgment) NO No history of cancer, except for non-melanoma skin cancers NO No known pregnancy at the time of enrollment NO No solid organ transplant or history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) ALL NO History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome ALL NO Primary pancreatic tumors pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors ALL NO Pancreatic metastasis from other malignancies ALL NO History of solid organ transplant, HIV/AIDS ALL NO Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible criteria) ALL NO Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up ALL NO Patients with known abnormal creatinine (glomerular filtration rate [GFR] < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP [yellow] subgroups) ALL NO Failure to agree for longitudinal follow-up ALL NO Known pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for >= 2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum human chorionic gonadotropin (B-HCG) pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 16.0-70.0, Calculus Biliary Age 16 to 70 years; Clinical presentation with biliary colic with or without jaundice; Serum elevation of at least one of the following enzymes: aspartate aminotransferase, alanine aminotransferase, glutamyl transpeptidase, alkaline phosphatase, and total bilirubin; Radiological findings suggestive of gallstones and concomitant common bile duct stones, with abdominal ultrasound showing possible CBD stones or a dilated CBD >8 mm in diameter. only patients with MRCP evidence of a CBD stone(s) were eligible after meeting all the previous criteria active acute pancreatitis, pregnancy, septic shock, intrahepatic gallstones, malignant pancreatic or biliary tumors, prior sphincterotomy, unfit for anesthesia and surgery, contraindications to MRCP and ERCP, liver cirrhosis, previous history of abdominal surgery (e.g., gastrectomy), and inability to give informed consent
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-55.0, Musculoskeletal Pain Analgesia Adverse Event Tricare beneficiaries between 18-55 years of age Triaged as Emergency Severity Index 4 or 5 Presenting to the William Beaumont Army Medical Center Emergency Department with a chief complaint of acute MSK pain (i.e., general muscular, neck, back, shoulder, arm, forearm, elbow, wrist, finger, hip, knee, thigh, leg, ankle, foot, or digits) Pain intensity of 20 mm or greater on a standard 100 mm visual analog scale Who the attending provider concurred with ketorolac IM administration for analgesia Body weight less than 50 kg (110 lbs.) Younger than 18 or older than 55 years Pregnant or breast feeding History of: confirmed, unconfirmed, known, unknown, or suspected peptic ulcer disease, intestinal hemorrhage, renal insufficiency, hepatic insufficiency, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, dark stools, bright red blood per rectum, hemoptysis, easy bruising, or high risk of bleeding Unable to confidently convey or unknown medical history Allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs or aspirin Systolic blood pressure <90 or >180 mmHg Pulse rate <50 or >150 beats/min Any over-the-counter or prescribed opioid and/or non-opioid analgesic medication (oral, per rectum, topical or parenteral) taken within 12 hours of ED presentation Advised by any medical provider to not receive NSAIDs for any reason
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-55.0, Vomiting Nausea Abdominal Pain Cannabis Use presenting to the emergency department with chief complaint of nausea or vomiting abnormal blood pressure (>200/100mmHg or <90/40mmHg) fever (>100.4F) acute trauma QT > 450ms on cardiac monitor altered mental status (GCS < 15) chest pain known allergy to haloperidol or ondansetron Parkinson's disease pregnancy or lactation use of any antiemetic in the previous 8 hours
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-70.0, Transversus Abdominis Plane (TAP) Block Acute stony cholecystitis Acute acalculous cholecystitis 70 years old Open cholecystectomy
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 35.0-55.0, Acute Coronary Syndrome Periodontitis for ACS group : • Patients diagnosed with both ACS and localized or generalized periodontitis of stage II or III with grade B or C. ACS patients myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) were hospitalized . Unstable angina (UA) was defined as the new onset or a changed pattern of angina over the past 2 months and Canadian Cardiovascular Society (CCS) class IV angina at the time of presentation coinciding with appropriate objective evidence of myocardial ischemia on an electrocardiogram (ECG) or myocardial perfusion imaging. ACS with ST-segment elevation was defined as AMI characterized by: chest pain, radiating or not to the upper extremities, lower jaw, upper back or epigastrium lasting 30 minutes or more, associated or not with sweating, nausea or pallor; presence of ST-segment elevation of 1 mm in two or more contiguous peripheral leads or 2 mm in two or more contiguous precordial leads on electrocardiogram (ECG); and elevation in serum markers of myocardial injury and necrosis (CK, CK-MB) three times their reference value28. Non-ST-segment elevation ACS on ECG was defined as a clinical condition similar to that mentioned above but with chest pain lasting less than 30 minutes, with or without elevation of serum enzyme markers of myocardial injury and necrosis (CK, CK-MB, cardiac troponins I and T). ACS patients were referred to the Department of Periodontology, Faculty of Dentistry, Selcuk University (Konya/Turkey) for periodontal examination in a one year period. for control group : • Patients diagnosed with localized or generalized periodontitis of stage II or III with grade B or C. Twenty-six age and sex-matched patients (43.04±8.35 years) with periodontitis (Group P) otherwise systemically healthy were recruited as control group in the Department of Periodontology, Faculty of Dentistry, Selcuk University (Konya/Turkey). Exclusions for both groups included metabolic disorders high blood pressure treated with antihypertensive medications periodontal therapy antibiotic treatment until 3 months prior the study. Smoking habits and education status were also recorded. ACS patients take aspirin (1 × 100 mg per day) during 1 month
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-70.0, Patients With Dyspeptic Symptoms After Cholecystectomy Aged 18-70 years old, male or female; 2. Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due to cholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors, non-functioning gallbladder; 3. Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including: abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite; 4. Signed informed consent, agreed to participate in this study Patients with abnormal liver function and renal function; 2. Patients with severe heart and lung dysfunction; 3. Patients with neurological, mental illness or other reasons can not cooperate with the study; 4. Patients with advanced malignant tumors or other serious wasting diseases, any unstable chronic diseases and acute diseases, interfere with the efficacy evaluation of this study (such as patients undergoing chemotherapy) and the completion of the trial plan; 5. Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugs and control drugs, and allergic to the test drugs and control drugs; 6. Patients who have taken digestive enzymes and cholagogue drugs by themselves; 7. Pregnant and lactating women; 8. Patients who are participating in other clinical trials; 9. Patients who cannot be followed up on time. Elimination 1. Failure to take medicine as required, that is,Failure to take medicine or missed doses ≥ 3 times within 1week; 2. Taking other digestive enzymes, cholagogues and prokinetic drugs or drugs affecting digestive enzymes and bile secretion and excretion during the study; 3. Adverse events occur, for the benefit of patients, doctors believe that the drug should not be continued; the results of such cases do not participate in the efficacy statistics, but are related to the safety evaluation. Drop-out 1. Cases with adverse events and patients are not willing to continue participating in the study. 2. Cases who voluntarily withdrew consent from the study due to poor efficacy and inconvenience in follow-up. 3. cases lost to follow-up due to various reasons
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Soft Tissue Sarcoma Malignant Peripheral Nerve Sheath Tumor (MPNST) Leiomyosarcoma Endometrial Stromal Sarcoma Written informed consent in accordance with federal, local, and institutional guidelines 2. Age > 18 years. 3. Patients must have histologically confirmed locally advanced/unresectable or metastatic STS 1. For Arm A the acceptable histologies are MPNST, ESS and LMS 2. For Arm B arm all STS histologies are eligible 4. Patients must fall into one of the three following categories: 1. Show evidence of progressive disease on study entry; or 2. Be treatment naïve, but have progressed since diagnosis; or 3. Newly diagnosed patients with de novo metastatic measurable disease. 5. Patient must have measureable disease as defined by 1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 7. Adequate hematopoietic function within 7 days prior to C1D1: 1. absolute neutrophil count (ANC) ≥1.0x109/L 2. hemoglobin ≥ 90 g/L 3. platelet count ≥100 x 109/L 4. Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study. 5. Patients must have: i. At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and ii. At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment. iii. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study. 8. Adequate hepatic function within 28 days prior to C1D1: 1. Bilirubin <1.5 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN) 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2 X ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, ALT/AST <5.0 X ULN is acceptable; 9. Adequate renal function within 28 days prior to C1D1: estimated creatinine clearance of ≥20 mL/min calculated using the formula of Cockcroft and Gault: (140-Age)(Weight in kg)(Constant)/(serum creatinine µmol/L); where constant is 1.23 for men and by 1.04 for women. 10. Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment. 11. Ability to swallow pills Has received selinexor or another XPO1 inhibitor previously 2. Patients who are pregnant or lactating 3. Radiation (except planned or on-going palliative radiation outside of the region of measurable disease), chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy. Mitomycin C and radio-immunotherapy within 6 weeks prior to cycle 1 day 1. 4. Major surgery within 4 weeks before initiation of therapy 5. Active, ongoing or uncontrolled active infection within one week prior to first dose 6. Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea; 7. Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Antiemesis and Palliative Care. 8. In the opinion of the Investigator, patients who are significantly below their ideal body weight (Body Surface Area ≤ 1.2m2) 9. Concurrent therapy with approved or investigational anticancer therapeutic agents 10. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-45.0, Pelvic Girdle Pain • Post-partum females with the normal vaginal delivery present with pelvic girdle pain before the next conception Aged between 18 and 45 Posterior pelvic girdle pain located distal and/or lateral to the L5-S1 Pain onset during pregnancy or within 3 weeks after delivery, most recent delivery within 6 to 16 weeks Positive posterior pelvic pain provocation (P4) test Patients presenting with the history of Back pain indicating radiculopathy Mechanical back pain Back pain due to disc herniation Rheumatological diseases Neurological illness or recent surgery Women who have gone through C-section
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 21.0-45.0, Analgesia Written informed consent from the patient Age: 21-45 years old Sex: both sex (males and females) Physical status: ASA 1& II BMI = (25-35 kg/m2) Type of operation: elective laparoscopic cholecystectomy Altered mental state Patients with known history of allergy to study drugs Advanced hepatic, renal, cardiovascular, and respiratory diseases Patients with chronic pain Patients receiving anticoagulants Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Minimal Residual Disease KRAS G12D KRAS G12R NRAS G12D NRAS G12R Pancreatic Ductal Adenocarcinoma Colorectal Cancer Non-small Cell Lung Cancer Ovarian Cancer Cholangiocarcinoma Bile Duct Cancer Gallbladder Carcinoma KRAS/NRAS mutated (G12D or G12R) solid tumor Positive for circulating tumor DNA despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable Screening CT is negative for recurrent disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Presence of tumor mutations where specific therapy is approved Known brain metastases Use of immunosuppressive drugs
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-50.0, Postoperative Pain Cesarean Section Pregnant women 50 years ASA I-II, -≥34th gestational week Patients with neuraxial anesthesia contraindications Patients allergic to drugs to be used in the study BMI> 35 kg / m2 Diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain Patients who have been given opioids in operation due to intraoperative pain Patients with unsuccessful spinal anesthesia who underwent general anesthesia Patients with excessive bleeding during the operation, uterine atony, placement of the drain in the area to be infiltrated Patients who do not want spinal anesthesia Cannot understand VAS History of drug addiction and psychiatric illness
|
0
|
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.
|
eligible ages (years): 0.0-999.0, Chronic Hepatitis C Fibrosis Hemolytic Anemia Age above 18 years, male or female. Serum alanine or asparate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 U/L) on an average of three determinations taken during the previous 6 months. The mean of the three determinations will be defined as "baseline" levels. Presence of anti-HCV and HCV RNA in serum tested at least once during the previous six months. Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22). Written informed consent If previously treated with interferon or ribavirin, must not have a lack of sustained virological response as shown by the presence of HCV RNA in serum six months after stopping therapy. Patients must not have received the combination of alpha interferon and ribavirin in the past. Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Pregnancy or, in women of child-bearing potential or spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermacide, or birth control pills, or an intrauterine device. Significant systemic or major illnesses other than liver disease, including congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, and angina pectoris. Pre-existing anemia (hematocrit less than 36% for men and less than 34% for women) or known history of hemolytic anemia. Antiviral or immunosuppressive therapy within the last 6 months. Evidence of another form of liver disease in addition to viral hepatitis (e.g., autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency). Any 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 one year. Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50 ng/ml (normal is less than 9 ng/ml) and /or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. Clinical gout
|
2
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Age above 18 years, male or female. Elevated alanine (ALT) or asparate (AST) aminotransferase activities averaging at least twice the upper limit of normal on three determinations taken at least one month apart during the previous 6 months. The mean of these three determinations will be defined as "baseline" ALT and AST levels. Presence of anti-HCV and HCV RNA in serum tested at least once during the previous six months. Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22). Contraindications to the use of alpha interferon, either in the form of specific contraindications to its use (depression, psychiatric illness, neurological impairment, severe thrombocytopenia, autoimmune disease), or the history of severe side effects or intolerance during a previous course of alpha interferon, or lack of a sustained virological (sustained lost of HCV RNA from serum for more than six months after stopping treatment) response to an adequate course (6 months) of the combination of alpha interferon and ribavirin or (after September 1, 2003) the combination of peginterferon and ribavirin. Written informed consent. FOR IN 98-DK-0003: An important group of patients who were enrolled in the current study, were patients who participated in the Clinical Research Protocol 98-DK-0003 (Combination of alpha interferon with long-term ribavirin for patients with chronic hepatitis C) and who did not have a sustained virological response to this treatment. These patients were eligible to enroll into the current study once they had finished the therapy and follow up period in that trial. These patients fit the listed above with one exception: some patients were receiving ribavirin monotherapy as a part of their participation in 98-DK-0003. These patients were eligible to be immediately enrolled into this study without a medication-free period in between Pregancy or, in women of childbearing potential, inability to practice adequate contraception. Men with spouses or sexual partners of childbearing potential also be excluded if they are unable to practice adequate contraception. Significant systemic illnesses other than liver disease, including a history of congestive heart failure, cerebral vascular disease, renal failure (creatinine clearance less than 50 ml/min), and angina pectoris. Patients with an abnormal stress test or carotid untrasound will not be enrolled into this study. Pre-existing anemia (hematocrit less than 32%) or known history of hemolytic anemia. Interferon or immunosuppressive therapy within the last 6 months. Evidence of another form of liver disease in addition to viral hepatitis, such as autoimmune or alcoholic liver disease. Active or recent (within one year) alcohol or drug abuse or psychiatric illness that is likely to interfere with compliance and requirements for safety monitoring during this study
|
2
|
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.
|
eligible ages (years): 0.0-999.0, Hepatitis C Patients with chronic hepatitis C. Age 18 to 70 years, male or female. HCV infection indicated by the presence of anti-HCV (by ELISA and recombinant immunoblot assay [RIBA]). Written informed consent. Women must not be pregnant. Patients must not have significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, uncontrolled diabetes mellitus. Patients must not have antiviral or immunosuppressive therapy within the last 6 months. Patients must not have HIV infection. Patients must not have contraindications to liver biopsy (mainly clotting abnormality (coumadin therapy, platelet count less than 50,000/cubic millimeter, prothrombin time more than 4 seconds beyond control))
|
2
|
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.
|
eligible ages (years): 16.0-999.0, HIV Infections Patients must have the following symptoms and conditions Treatment naive Recent HIV infection Baseline laboratory values within acceptable ranges Written, informed consent from parent or legal guardian for patients < 18 years old Available for follow-up for at least 96 weeks Co-existing Condition: Patients with the following conditions and symptoms are excluded Documentation of other cause for previously mentioned clinical conditions Intractable diarrhea Signs and symptoms of bilateral peripheral neuropathy >= Grade 2 Inability to tolerate oral medication Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted No other anti-HIV therapy allowed Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed). 1. Any prior antiretroviral therapy Prior vaccination with a candidate HIV therapeutic vaccine Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment
|
0
|
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.
|
eligible ages (years): 18.0-70.0, Cholangitis, Sclerosing Liver Cirrhosis, Biliary ENTRY --Disease Characteristics-- Pathologically confirmed primary sclerosing cholangitis (PSC) meeting the following Chronic cholestatic disease for at least 6 months Liver biopsy within the past 6 months compatible with the diagnosis of PSC Intra and/or extrahepatic biliary duct obstruction, beading, or narrowing OR Pathologically confirmed primary biliary cirrhosis (PBC) that is experiencing suboptimal response to ursodeoxycholic acid and meeting the following Chronic cholestatic liver disease for at least 6 months Positive antimitochondrial antibody No biliary obstruction by ultrasound, CT, or cholangiography Prior liver biopsy compatible with diagnosis of PBC Received ursodeoxycholic acid for at least 6 months --Prior/Concurrent Therapy-- Biologic therapy At least 3 months since prior D-penicillamine No planned transplantation for at least 1 year Chemotherapy
|
0
|
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.
|
eligible ages (years): 0.0-999.0, Hepatitis C Persistent infection with mild hepatitis that is non-progressive
|
0
|
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.
|
eligible ages (years): 2.0-999.0, Hepatitis C Liver Disease Patients who have recovered from past HCV exposure (positive anti-HCV but negative HCV viremia and absent liver disease). Patients with asymptomatic HCV infection (positive anti-HCV and HCV viremia, but persistently normal or minimally elevated ALT and normal or mild disease on liver biopsy). Patients with active liver disease (positive anti-HCV and HCV viremia, persistently elevated ALT and/or moderate disease on liver biopsy). Patients with active extrahepatic manifestations of HCV infection (cryoglobulinemia, glomerulonephritis, vasculitis, etc.). Patients with rapidly progressive, severe liver disease and/or hepatocellular carcinoma. Patients who have undergone or are undergoing treatment. Patients from a single-source outbreak of HCV infections (in which the viral factors should be identical and the patients are often from a homogeneous population with less genetic variability). HCV infected family members and twins. Patients with other forms of liver disease including HBV infection, primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, hemochromatosis, and Wilson's Disease, as well as normal volunteers Adult subjects with a Hct of less than 30 or pediatric subjects less than 25 will be excluded. Children with HCV infection younger than 2 years of age will be excluded. Unaffected healthy volunteers who are minors are not eligible for this study
|
0
|
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.
|
eligible ages (years): 18.0-70.0, Hepatitis C English speaking/reading Serum positive for HCV virus by PCR Elevated alanine transferase (ALT) within 6 months of the Entry Visit, unattributable to causes other than HCV Liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic HCV Laboratory parameters available at the Entry Visit including CBC, differential, and platelet count
|
0
|
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.
|
eligible ages (years): 0.0-999.0, Chronic Hepatitis C Age 18 years or above, male or female. Serum alanine or asparate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 IU/L). Presence of anti-HCV in serum. Presence of HCV RNA genotype1 in serum at levels above 10,000 copies/ml. Previous adequate therapy with alpha interferon and ribavirin without a sustained virological response. An adequate course of therapy is defined as at least 24 weeks of alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in starting doses of at least 1000 mg daily. Patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible. Written informed consent Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Pregnancy, or 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 spermacide, or birth control pills, or an intrauterine device. Significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression. Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)). 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). Active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months. Serious autoimmune disease that, in the opinion of the investigators, might be worsened by interferon therapy, such as lupus erythematous, rheumatoid arthritis or Crohn's disease. Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. Human immunodeficiency virus infection, as shown by presence of anti-HIV
|
2
|
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.
|
eligible ages (years): 16.0-999.0, Chronic Hepatitis B Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection Documentation of positive Hepatitis B e antigen (HBeAg) status The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV) The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)
|
0
|
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.
|
eligible ages (years): 16.0-999.0, Chronic Hepatitis B Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection HBeAg negative, anti-HBeAb positive Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV) Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis C, Chronic Signed written informed consent Age over 18 years old Presence of HCV RNA measured by qualitative PCR Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 3 months (12 weeks) Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin Liver biopsy consistent with cirrhosis or progression to cirrhosis (METAVIR fibrosis score 3 to 4) due to chronic hepatitis C within the last 12 months before treatment starts, and at least 6 months after the end of the prior failed therapy Cirrhosis classified as Child-Pugh "A" (no more than 6 points) Compensated liver disease with prothrombin time prolonged less than 3 seconds over control, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, bleeding varices or a history of detection of stigmata of recent bleeding on existing varices or ascites Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC Hematocrit > 30%, platelet count > 75,000, WBC > 2,500, and absolute neutrophil cell count > 1,500 Use of systemic corticosteroids within 6 months of entry Evidence of drug-induced liver injury Current use of any drug known to have or suspected of having therapeutic activity in hepatitis C, or any immunosuppressive drug (including corticosteroids) Evidence of any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease Alpha-fetoprotein > 200 ng/mL Child-Pugh "B" or "C" cirrhosis (score of 7 or more points), either currently or at any occasion in the past Decompensated liver disease based on a history of hepatic encephalopathy, bleeding varices or a history of detection of stigmata of recent bleeding on existing varices, or ascites HIV infection diagnosed by HIV seropositivity and confirmed by Western blot Concomitant or prior history of malignancy other than curatively treated skin cancer or surgically cured in situ carcinoma of the cervix Active infectious process other than HCV that is not of a self-limited nature
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis C, Chronic Signed written informed consent Age over 18 years old Presence of HCV RNA measured by qualitative PCR Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 12 weeks Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin Liver biopsy consistent with chronic hepatitis C within the last 12 months before treatment starts, and at least 6 months after the end of the prior failed therapy No clinical or histological evidence of cirrhosis (METAVIR fibrosis score 0 to 3) Compensated liver disease with prothrombin time prolonged less than 3 seconds over control, serum albumin stable and within normal limits, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, esophageal varices or ascites Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC Hematocrit > 30%, platelet count > 100 x 109/L, WBC > 3 x 109/L, and polymorphonuclear white cell count > 1.5 x 109/L Use of systemic corticosteroids within 6 months of entry Current use of any drug known to be hepatotoxic, any drug (other than the study drugs) known to have or suspected of having therapeutic activity in hepatitis C or of any immunosuppressive drug (including corticosteroids) Any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease Alpha-fetoprotein > 200 ng/mL Current or past diagnosis of cirrhosis Evidence of portal hypertension either by Doppler ultrasonography or gastrointestinal endoscopy Decompensated liver disease based on a history of hepatic encephalopathy, esophageal varices, or ascites HIV infection diagnosed by HIV seropositivity and confirmed by Western blot Concomitant or prior history of malignancy other than curatively treated skin cancer or surgically cured in situ carcinoma of the cervix Active infectious process other than HCV that is not of a self-limited nature (eg. TB or AIDS)
|
1
|
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.
|
eligible ages (years): 18.0-75.0, Liver Fibrosis Cirrhosis Men or women 18 to 75 years Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) Must meet minimum blood chemistry requirements Cannot have unstable or uncontrolled thyroid disease Cannot have a variety of other diseases (listed in protocol Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study
|
2
|
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.
|
eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection No fibrolamellar HCC No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study Surgery Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques Must have paraffin tissue block or unstained slides from biopsy or surgical specimen No known brain metastases
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C Age above 18 years, male or female. Presence of anti-HCV in serum. Positive HCV RNA determination in serum. HCV genotype 2 or 3 as determined by Inno LiPa assay or by direct sequencing. Patients with mixed genotypes will not be eligible if they have genotypes other than 2 or 3. Written informed consent Previous treatment with interferon alpha or peginterferon. Decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Pregnancy or, 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 spermicidal, or birth control pills, or an intrauterine device. Significant systemic or major illnesses other than liver disease, including congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease not controlled by psychotropic agents, and angina pectoris. 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. Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 30%), neutropenia (less than 1000 neutrophils/microliter) or thrombocytopenia (less than 70,000 cells/microliter). History of hemolytic anemia. Evidence of another form of liver disease in addition to hepatitis C (for example hepatitis B, autoimmune liver disease, Wilson's disease, alcoholic liver disease). Active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months. Evidence of hepatocellular carcinoma: either alfa-fetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. Clinical gout. HIV infection. Quiescent or active, serious autoimmune disease such as lupus erythematosus, ulcerative colitis, Crohn's disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alfa interferon. The use of immunosuppressive medications, including corticosteroids in doses of 10 mg of prednisone or its equivalent and higher
|
1
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed 2. Male or female 18 years of age or older 3. Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA 4. Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV. 5. Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy 2. Specific laboratory abnormalities at Screening 3. Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up 4. Recent depression or psychiatric disorders 5. Known HIV infection or positive HIV antibody test at Screening 6. Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at Screening 7. Unstable or uncontrolled thyroid disease 8. Presence or history of non-HCV chronic liver disease 9. History of unstable or deteriorating cardiovascular or cerebrovascular disease within 6 months prior to Screening 10. Current or history of neurologic disorder within a specified time frame 11. A disease known to cause significant alteration in immunologic function including hematological malignancy, sarcoidosis or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, psoriasis, inflammatory bowel disease, multiple sclerosis etc.) 12. History of major organ transplantation (i.e., liver, kidney, lung, or heart) with an existing functional graft, including bone marrow transplant or stem cell transplant 13. Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as cyclosporine, azathioprine, chronic systemic corticosteroids, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy 14. Pregnant or lactating women 15. Liver biopsy within the past three years documenting cirrhosis
|
1
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis B Chronic Hepatitis D Be positive for both anti-HDV and HBsAg for more than 6 months Present with elevated serum ALT levels at least 1.5 times the upper limit of normal, documented on two occasions (at least one month apart), within six months prior to enrollment Be HDV RNA positive by PCR (sensitivity: 103 copies/mL) [Yamashiro et al, 2004] Be HBV DNA positive by PCR Present with liver biopsy findings compatible with the diagnosis of chronic liver disease (the liver biopsy needs to be taken within 52 weeks prior to enrollment) Have adequate liver reserve (defined as equal to or better than Child-Pugh Class A) Present with WBC ≥3000/mm3, ANC ≥1500/mm3, and platelet ≥80,000/mm3 Be able to and likely to attend regularly for treatment and follow-up Give their written informed consent Be negative for urine pregnancy test (for females of childbearing potential), documented once within the screening period and again within 24 hours prior to the first dose of study drug Drug addicts or have any history or histological evidence of alcohol abuse, or currently receive prescriptions that may cause hepatotoxicity Have decompensated cirrhosis as coded by Child-Pugh classification (i.e. history of ascites, history of bleeding from esophageal varices, severe portal hypertension, serum albumin <30 g/l, serum bilirubin >30 mg/l) Present with WBC <3000/mm3, ANC <1500/mm3, or platelets <90,000/mm3 Present with hemoglobin <12.0 gm/dl for female and <13.0 gm/dl for male Have been treated with immunosuppressive therapy within the past six months (e.g. steroids, azathioprine, cyclophosphamide) Have renal insufficiency (serum creatinine >150 μmol/l) Have clotting abnormalities which preclude a liver biopsy Have evidence of any serious neurological dysfunction Have obesity or diabetes mellitus-induced liver disease Have serological evidence of autoimmune chronic liver disease (e.g. antinuclear antibody titers >1:320, and/or smooth muscle antibody titers>1:160)
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C At least 18 years of age Chronic hepatitis C infection based on history and detectable serum HCV RNA Documented failure to respond to or relapse after treatment with pegylated interferon and ribavirin combination therapy Adequate hematologic function (absolute neutrophil count [ANC] greater than or equal to 1,500 cells/uL, hemoglobin [Hgb] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males, platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL) Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min) Normal coagulation profile (PT/INR and aPTT within institutional normal limits) D-dimer within institutional limits Female patients of childbearing potential must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception Prior exposure to any chimeric antibody Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease Decompensated clinical liver disease or cirrhosis Any evidence of clinically significant bleeding Known history of bleeding diathesis or coagulopathy Any history of thromboembolic events including central venous catheter-related thrombosis Any evidence or history of a hypercoagulable state (eg, elevated d-dimer or shortened aPTT) Concurrent therapy with oral or parenteral anticoagulants Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen) Antiviral therapy within 90 days of day 0
|
1
|
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.
|
eligible ages (years): 18.0-70.0, Hepatitis C Male and female patients between 18-70 years of age Evidence of chronic hepatitis C by detectable serum HCV-DNA Hepatitis C genotype 1,2,3 or 4 Indication for antiviral therapy of hepatitis C according to current clinical guidelines Written informed consent History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study Abnormal thyroid stimulating hormone (TSH) Presence of contra-indications for antiviral therapy Concurrent psychiatric axis I diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) as the presence of a major depressive episode, bipolar disorder or psychotic disorder Concurrent use of psychotropic drugs such as MAO-inhibitors, St John's wort, Lithium and 5 HT-agonists and antiepileptics
|
0
|
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.
|
eligible ages (years): 13.0-16.0, Hepatitis Eligible children are those who received the 2.5 µg/dose three-dose series of Recombivax HB® with the first dose having been given during the first week of life and the series completed by 9 months. All children were born to HBsAg negative mothers, had no HBsAg-positive persons living in their households at the time of immunization, and had a minimum of one serologic specimen prior to the age of 18 months with results indicating an anti-HBs concentration of ≥10mIU/mL Receipt of a fourth dose of any hepatitis B vaccine History of allergic reaction after receiving hepatitis B vaccine or hypersensitivity to any components of the hepatitis B vaccine used for the booster dose History of hepatitis B virus infection Existence of disease known to affect the immune system (e.g., HIV, AIDS, SCID, chronic renal disease, cancer) Current or recent (within 6 months) receipt of immunomodulatory therapy (e.g., systemic corticosteroids, chemotherapy) or blood products
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Fibrosis Chronic viral hepatitis C, genotype 1 or 4 Fibrosis F3 or F3-F4, assessed by the scoring Metavir system Initial treatment against HCV Psychiatric pathology Alcool consummation Pregnancy or plan of pregnancy Breastfeeding
|
1
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Positive anti-HCV antibodies Positive HCV RNA (quantitative method) Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months Without lower dosage during previous treatment Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA Metavir over F2 on the most recent biopsy ALT increase over normal value twice during last 6 months HIV infection Psychiatric pathology Alcool consummation Cirrhosis Pregnancy or plan of pregnancy Breastfeeding
|
1
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C, HCV Genotype 1 Age 18 HCV RNA positive HCV genotype 1 Histologically proven chronic hepatitis No previous antiviral treatment Liver histology showing cirrhosis Decompensated liver function WCC < 1500/mm3 or platelet count <90,000/mm3 Co-infection with HIV or HBV/HAV Alcohol intake greater than 40 units/week Current intravenous drug dependence Pregnancy or breast feeding of infants Inadequate contraception Neuropsychiatric disorder Neoplastic disease
|
1
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis B, Chronic Hepatitis C, Chronic Male and female patients >= 18 years of age will be recruited Patients with dual chronic hepatitis C and B must be positive for both anti-HCV and HBsAg for more than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS HCV Test version 2.0) Patients must not be positive for HBeAg Patients with monoinfected chronic hepatitis C must be positive for anti-HCV for more than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS HCV Test version 2.0). Patients must not be positive for HBsAg. All patients must Be treatment naïve for the hepatitis disease or have had treatment failure to previous interferon monotherapy or treatment failure to previous lamivudine therapy Present with elevated serum ALT levels at least 1.5 times the upper limit of normal, documented on two occasions (at least one month apart), within six months prior to enrollment Present with liver biopsy findings compatible with the diagnosis of chronic liver disease (the liver biopsy needs to be taken within 52 weeks prior to the first dose of study drug) Have adequate liver reserve (defined as equal to or better than Child-Pugh Class A) Present with WBC 3500/mm3, ANC 1500/mm3, and platelets 90,000/mm3 Be drug addicts or have any history or histological evidence of alcohol abuse, or currently receive prescriptions that may cause hepatotoxicity Present with hemoglobin <12.0 gm/dl for females and <13.0 gm/dl for males Signs or symptoms of hepatocellular carcinoma Any investigational drug ? 6 weeks prior to the first dose of study drug Have renal insufficiency (serum creatinine concentration >1.5 x upper limit of normal at screening; upper limit depending on lab at each site) Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated Have serological evidence of autoimmune chronic liver disease (e.g. antinuclear antibody titers > 1:320, and/or smooth muscle antibody titers > 1:160) History of major organ transplantation with an existing functional graft History 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 Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
|
1
|
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.
|
eligible ages (years): 18.0-65.0, Hepatitis C, Chronic The patient must be 18 to 65 years of age, inclusive Primary diagnosis of chronic HCV infection Patients who did not respond or relapsed following therapy with interferon
|
1
|
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.
|
eligible ages (years): 18.0-85.0, Hepatitis C Hepatitis B Autoimmune Hepatitis Liver Cirrhosis, Biliary Cholangitis, Sclerosing patients who have a liver biopsy as standard of care and are diagnosed with either patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada Hepatitis C Hepatitis B Autoimmune Hepatitis Primary Biliary Cirrhosis Primary Sclerosing Cholangitis
|
0
|
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.
|
eligible ages (years): 18.0-80.0, Hepatitis C HIV Infections Sera available and appropriate for testing, including serial sera over a period of time (retrospective analysis) 2. HIV serology positive. 3. Unequivocal HCV antibody positive or HCV RNA positive Those without sera available. 2. Those unwilling to give informed consent. 3. Persons with hepatitis B virus infection, as defined by the presence of hepatitis B surface antigen and/or hepatitis B virus DNA positive
|
0
|
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.
|
eligible ages (years): 18.0-70.0, Hepatitis C HCV mono-infection, no coagulopathy and having a liver biopsy for consideration of treatment Infection with HIV or HBV, excess ethanol (EtOH) consumption and other diseases of the liver
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C HIV Infections This is not a clinical trial HCV infected and uninfected (controls) Women Minorities Children Individuals who cannot or will not provide informed consent
|
2
|
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.
|
eligible ages (years): 18.0-85.0, Hepatitis C Hepatitis B patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada Male and female patients Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test Detectable serum HCV-RNA Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug All fertile males and females receiving Copegus must be using two forms of effective contraception during treatment and during the 6 months after treatment end All patients should have insulin resistance (>2.1) determined by the homeostasis model assessment (HOMA) method Women with ongoing pregnancy or breast feeding 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 Any investigational drug < 6 weeks prior to the first dose of study drug Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV) 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) Signs or symptoms of hepatocellular carcinoma 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 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
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Serologic evidence of chronic hepatitis C infection by an anti-HCV test Serum HCV-RNA quantifiable at > 600 IU/mL or 1000 copies/mL by the Roche HCV Test, v2.0 Patients with both normal or elevated serum ALT are eligible Compensated liver disease (Child-Pugh grade A clinical classification) Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasonography, CT scan or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24 hour period prior to first dose of study drug All fertile males and females receiving RBV must be using two forms of effective contraception during treatment and during the 6 months after treatment ends Women with ongoing pregnancy or breat feeding Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic soses 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, HBsAg, anti-HBsAg, anti-HBc Ab, anti-HIV Ab History or 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 evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease Neutrophil count < 1500/mm or platelet count < 90,000 cells/mm at screening Serum creatinine level > 1,5 times the ULN at screening History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or neuroleptica 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 psychiatric disease History of severe seizure disorder or current anticonvulsant disease History of immunologically mediated disease (e.g. IBD, ITP, LED, AIHA, scleroderma, severe psoriasis or RA etc.)
|
0
|
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.
|
eligible ages (years): 20.0-70.0, Hepatitis C, Chronic Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses Hemoglobin levels<8.5g/dL Platelet counts<50,000/mm3 Total polymorphonuclear counts<1000/mm3 Pregnancy Renal dysfunction
|
2
|
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.
|
eligible ages (years): 0.0-999.0, Hepatitis C Virus Healthy volunteers, no liver disease Chronic infection with hepatitis C virus Other chronic liver disease unrelated to hepatitis C virus Subjects in all groups must have sufficiently healthy veins to allow blood collection Any medical condition that, in the opinion of the investigators, precludes the patient's participation
|
2
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C Hepatitis, Viral, Human Hepatitis C virus (HCV) genotype 1 Previous therapy with pegylated interferon and ribavirin Documented previous treatment failure Hepatic dysfunction Coinfection with hepatitis B or HIV Other unrelated liver diseases Liver cancer
|
2
|
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.
|
eligible ages (years): 20.0-999.0, Hepatitis C Hepatitis C patients (high titer, genotype1) Patients with autoimmune disorder Patients with negative HBs antigen Patients with hepatic cirrhosis, hepatic failure and hepatic cancer Patients with depression or psychoneurotic disorder
|
2
|
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.
|
eligible ages (years): 18.0-70.0, Hepatitis C Must have documented failure to respond to past treatment with a Pegylated IFN + RBV. Failure to respond to past treatment is defined as positive HCV RNA at 12 weeks and less than a 2 log drop from baseline; OR positive HCV RNA and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive HCV RNA Must have tolerated previous hepatitis C therapy Must be off hepatitis C therapy for 3 months prior to study participation Must have had a liver biopsy within the past 5 years Decompensated liver disease Laboratory abnormalities as per protocol HIV+ Autoimmune disease Unstable or deteriorating cardiovascular or cerebrovascular disease History of seizures in past 5 years Alcohol or drug abuse in past year Pregnant or lactating women
|
0
|
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.
|
eligible ages (years): 18.0-60.0, Chronic Hepatitis B Adult male or female, 18 to 60 years of age chronic hepatitis B patients Patient must have documented positive serum HBsAg for a minimum of 6 months prior to entry into study. Patients must show evidence of HBV replication and hepatitis documented by Positive serum HBV-DNA within 3 months prior to entry (HBV-DNA > 2.5 pg/ml) Positive serum HBeAg within 3 months prior to entry. Documented presence of abnormal alanine aminotransferase (ALT) twice within 3 months prior to entry (2 to 10 fold above the upper normal level) Liver biopsy finding shows chronic hepatitis without liver cirrhosis Compensated liver disease with the following minimum hematological and serum biochemical Hemoglobin values of ≥ 12 gm/dL for both sexes WBC ≥ 3,000/mm3 Neutrophil count ≥ 1,500/ mm3 Platelets ≥ 100,000/ mm3 Total bilirubin ≤ 2 mg/dL Albumin ≥ 3.5 g/dL Uric acid within normal ranges Serum creatinine ≤ 123.76 mmol/L (≤1.4 mg/dL) Fasting blood sugar ≤ 6.38 mmol/L (≤115 mg/dL) for non-diabetic patients Patients older than 60 years of age Any cause for the liver disease based on patient history or biopsy (where applicable) other than chronic hepatitis B, including but not limited to: Co-infection with HCV and/or HIV Hemochromatosis (iron despistion > 2 + in liver parenchyma) Alpha-1 antitrypsin deficiency Wilson's disease Renal or liver transplant patients Autoimmune hepatitis Alcoholic liver disease Obesity related liver disease Drug related liver disease Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, hepatic encephalopathy. Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the treatment such as: Pre-existing psychiatric condition, especially severe epression, or a history of severe psychiatric disorder CNS trauma or active seizure disorders requiring medication. Patients with any history of cardiovascular dysfunction. Patients with any hemoglobinopathy including but not limited to thalassemia major and minor Poorly controlled diabetes mellitus Chronic pulmonary disease Immunologically mediated disease Clinical gout Sexually active females of childbearing potential must be practicing adequate contraception, Sexually active males must be practicing acceptable methods of contraception (vasectomy, condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy. Female patients must not breast feed during the treatment period. Patients must agree to limit the drinking of alcohol during the course or the treatment. Patients receiving Chinese herbal medication during the past 3 months prior to study entry. Patient who did not respond to previous interferon therapy or who relapsed after a previous course of Interferon therapy. Patients who have been enrolled in any clinical trial for the treatment of chronic hepatitis B
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis, Chronic Active HCV positive subjects documented by serum HCV RNA concentration > 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of > 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) not resulting in a minimum of a 2 log decrease in HCV RNA concentrations while on treatment (null responders). Or, receipt of adequate previous treatment PEG-IFN and RBV therapy for a minimum of 24 weeks (PEG-IFN alpha-2a doses of ≥ 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) resulting in a minimum of a 2 log decrease in serum HCV RNA concentrations by 12 weeks of treatment but not resulting in an undetectable viral load after 24 weeks of treatment (partial responders). If dose modifications were necessary during the treatment due to adverse events, the subject must have received at least 80% of the PEG-IFN dose and 80% of the RBV dose to be eligible for the study. HCV genotype 1 only; other HCV genotypes are excluded. Adults, 18+ years old Written informed consent Liver biopsy within 5 years of the first dose of study drug, documenting changes consistent with hepatitis C Adequate bone marrow, liver, and renal function demonstrated by Hemoglobin > 12 g/dL for females and > 13 g/dL for males White blood cell (WBC) > 3,000/mm3 Neutrophils > 1,500/mm3 Platelets > 80,000/mm3 Total bilirubin < 1.6 mg/dL Direct bilirubin < 1.5 upper limit of normal. If indirect bilirubin is elevated, Gilbert's disease must be documented in chart and substantiated Albumin > 3.7 g/dL and < 4.9 g/dL Serum creatinine < upper limit of normal per central laboratory. If serum creatinine is > upper limit of normal then calculated creatinine clearance has to be > 100 mL/min (by Cockcroft-Gault formula) for patient to be eligible. Negative pregnancy test in women of childbearing potential. Females of childbearing potential and males who have partners of childbearing potential must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded. Serum thyroid stimulating hormone (TSH) levels within normal ranges within 21 days of first study treatment, regardless of treatment with L-thyroxin Treatment with any IFN based therapies and/or antiviral therapies within 30 days of the first dose of study drug Subjects who have previously received an HCV vaccine Child-Pugh Class B or C History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Subjects with mild to moderate depression in the past who have a normal to mild Beck Depression Inventory score and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment. 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 atrial or ventricular cardiac arrhythmias) History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogeneic 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. Other serious medical conditions including, but not limited to HIV-1 Hepatitis B (positive hepatitis B surface antigen [HBsAg]) Cancer (active tumors in the last 5 years) Pregnant, partners of pregnant women, or nursing women Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of steroids or any anti-metabolite therapies within 3 months of entry into the study (inhaled and topical corticosteroids are permitted). Receipt of any vaccine or immunoglobulin within 30 days before the first dose of study drug. Flu vaccines are only allowed once the subjects are qualified for 36 additional weeks of treatment. Prior administration of oligodeoxynucleotides (including study medication CPG 10101), ribozymes, or any known allergy to CPG 10101, interferon, RVN or their excipients. Receipt of any investigational drug therapy within 30 days before the first dose of study drug. Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis, Autoimmune Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis Subjects with a hematocrit of <25
|
1
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis B Hepatitis A Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study Written informed consent will be obtained from each subject before the blood sampling visit of each year
|
0
|
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.
|
eligible ages (years): 7.0-17.0, Hepatitis B Hepatitis A Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis B Hepatitis A Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points Written informed consent will have been obtained from each subject. before the blood sampling visit of each year
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Hepatitis C male or female patients between 18 and 65 years of age; 2. female patients must be either postmenopausal, surgically sterile, or non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the study. Female patients of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control during the entire duration of the study. Male patients may be either surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during screening, the treatment period and for 6 weeks following the XTL6865 dose; 3. patient has been persistently HCV RNA-positive and remains HCV RNA-positive at screening (patient must have HCV RNA-concentrations which are at least 2 logs above the assay cut-off of 600 IU/mL) and HCV antibody (anti-HCV) positive; 4. patient is negative for human immunodeficiency virus (HIV), hepatitis delta virus (HDV), and has no evidence of chronic hepatitis B virus (HBV) infection (assessed by Hepatitis B surface antigen or HBV DNA in blood within 3 months of Day 1 of the study) or other clinical signs, symptoms, or laboratory abnormalities (e.g. amino transferases) leading to the a diagnosis of current acute Hepatitis B disease; 5. patient is in reasonably good health, as determined by the Investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests, except for findings related to their hepatitis C positive status. 6. subject's private physician has been informed of the subject's planned participation in the study; 7. capable of understanding and complying with the protocol, willing to reside in the study unit during the study period and to cooperate fully with the Investigator and site personnel, and must have signed the informed consent document prior to performance of any study-related procedures; 8. infected with HCV genotype 1 9. failed previous treatment for HCV infection with an approved regimen of IFN/RBV or pegylated IFN/RBV. Treatment failure includes both non-response (defined as a patient who did not experience a > 2 log decrease in HCV RNA after 12 weeks of treatment or who failed to clear virus to below the limits of detection after 24 weeks of treatment) or relapse (defined as re-emergence of detectable concentrations of HCV RNA after response to treatment). Treatment must have been discontinued at least 3 months prior to Day 1 of the study liver transplant patients; 2. patients with diabetes and HbA1c at screening of 7% or more; 3. patients who have previously received HCV-AbXTL68; 4. women who are pregnant, lactating, or have a positive serum pregnancy test at screening or positive urine pregnancy test on Day 1 at check-in; 5. patient has hemoglobin < 11 g/dL for women and 12 g/dL for men, platelet count < 50,000 cells/mm3, bilirubin > 3 mg/dL, serum creatinine > 1.5 x normal, INR >1.5 x normal, ALT > 5 x upper limit of normal, or serum albumin < 3.0 g/dL (at screening); 6. patient has a history or evidence of advanced or decompensated liver disease, ascites, encephalopathy, bleeding esophageal varices, hematuria or proteinuria, alcohol or intravenous drug abuse (within <= 1 years), fulminant liver failure, acute hepatitis from any source, periarteritis nodosa, serum sickness, an acute infectious illness, severe psychiatric disorder (including major depression), organic brain disorder, mental retardation, or other clinical conditions or diseases which in the judgment of the Investigator would interfere with the study or confound the results; 7. patient has present active malignancy (except for superficial cancers) 8. past history of pulmonary embolus, deep vein thrombosis, or current therapy with heparin or warfarin; 9. patient has a history of pulmonary hypertension; 10. patient with hypertension that is not, in the investigator's opinion, adequately controlled by medication (DBP > 90 and SBP > 140). In order to assess PK in the fasted state, patients should be able to delay administration of prescribed anti-hypertensive medicine for several hours without anticipating undue risk of medically significant increases in blood pressure. Patient should be on a stable anti-hypertensive regime for at least 30 days prior to screening with no changes in anti-hypertensive medications. 11. patient is currently receiving antiviral therapy for HCV; 12. patient has received IFN/RBV or pegylated IFN/RBV treatment within 3 months of study entry (Day 1); 13. immunomodulatory therapy (eg, systemic corticosteroids or interferon) within 3 months of study entry (Day 1); 14. any patient who does not meet the conditions for prior and concomitant treatments described in Section 6.6 of this protocol; 15. any patient considering or scheduled to undergo any surgical procedure during the study; 16. has taken any other investigational drug during the 30 days prior to screening visit; 17. has donated or lost more than a unit of blood within 30 days prior to screening visit; 18. has any condition(s) that in the Investigator's opinion would: a) warrant from the study or b) prevent the patient from completing the study; 19. has limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Liver Fibrosis Adults over 18 With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum) Not responders to a previous antiviral treatment using the interferon plus ribavirin combination With a wash-out of treatment for at least 6 months With an active chronic hepatitis C and a Metavir fibrosis score ≥ 2 Serum ALT levels > upper limit of the laboratory on two occasions within 6 months before Accepting to undergo a liver biopsy at the end of the study Negative pregnancy test for women With a social security cover Written informed consent History of hepatic complications History of transplantation History of severe seizures History of severe psychiatric disorders Drug addiction within the last 12 months Associated condition susceptible to be responsible for liver fibrosis Hepatocellular carcinoma Cardiovascular disease unstable under treatment Uncontrolled diabetes Retinopathy
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Hepatitis C Anemia Signed Informed Consent HCV infected patients confirmed by PCR or branched DNA (b-DNA) Scheduled to commence combination RBV/IFN or RBV/PEG-IFN therapy on Day 1 Normal serum creatinine Life expectancy > 6 months HIV-infected patients History of any primary hematologic disease Anemia attributable to factors such as iron or folate deficiency, pre-treatment hemolysis or gastrointestinal bleeding Has suspected or confirmed significant hepatic disease from an etiology other than HCV (e.g. alcohol, HBV, autoimmune disease etc) Current, active substance abuser Pregnant or breast feeding Women of childbearing potential not taking adequate birth control measures Exposure to Epoetin alfa within three (3) months prior to study enrollment or during study
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Coinfection With Hepatitis B Virus and Hepatitis C Virus Monoinfection With Hepatitis C Virus Patients who were randomized, treated and returned for follow up in the ML17862 protocol will be eligible for in this protocol Patients unwilling to provide informed consent or abide by the requirements of the study Patients who have already initiated anti-HCV or HBV treatment, approved or investigational since completion of the original protocol
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C Non-Alcoholic Fatty Liver Disease Subjects will be eligible for enrollment in this study if they meet the following Males or females; age at least 18 years at screening Abnormal ALT > 65 IU/L (ie, approximately 1.5 x upper limit of normal) Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of silymarin. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on drug and during follow-up) Hepatitis C virus (HCV) patients Previous treatment with any interferon-based therapy without sustained virological response Serum HCV RNA above quantifiable level of detection by the assay, within 1 year of screening and after the end of therapy No antiviral therapy for at least 6 months prior to screening visit Nonalcoholic fatty liver disease (NAFLD) patients Liver biopsy compatible with NAFLD within 3 years of screening Subjects with any of the following will not be eligible for participation Use of silymarin or other milk thistle preparations within 30 days of screening Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, within 30 days of screening. A multivitamin at standard doses will be allowed Allergy/sensitivity to milk thistle or its preparations Use of silymarin or other antioxidants (as above) during the screening period Use of warfarin, metronidazole or chronic use of acetaminophen greater than two gram per day Previous liver biopsy that demonstrated presence of cirrhosis Previous liver biopsy that demonstrated greater than or equal to 15% steatosis or evidence of steatohepatitis for HCV cohort Positive test for anti-HIV or HBsAg within 3 years of screening Positive urine drug screen for drugs of abuse at screening
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Age ≥18 years Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis HCV genotype 4 Patients that have not previously received peginterferon Patients unable to take oral medications Use of ribavirin within 30 days prior to enrollment Females who are either pregnant, breast-feeding or not using birth control and are sexually active Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027 Patients with other causes of liver disease Transplant recipients receiving immune suppression therapy Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay Patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores >6 Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 grams per day Patients who are clinically unstable
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Age ≥ 18 years Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis Patients unable to take oral medications Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active Any investigational drug therapy within 30 days prior to enrollment Patients with other causes of liver disease Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay Patients with history of alcoholism or with an alcohol consumption of >40 grams per day Patients who are clinically unstable Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets
|
2
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Age ≥18 years Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis HCV genotype 4 Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy Females who are either pregnant, breast-feeding or not using birth control and are sexually active Males whose female partners are pregnant Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease) Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus Patients with a history of alcoholism or with an alcohol consumption of >40 grams per day Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia) Patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets
|
1
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C Willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures 2. Aged between 18-65 years 3. Documented history of chronic HCV infection (for at least 6 months prior to study entry) as diagnosed by either: 1. Anti-HCV positive or 2. HCV RNA viral load positive by PCR 4. Be a non-responder to or unsuitable for interferon based therapy. 5. Have liver inflammation, as defined by either AST and/or ALT levels 2-10 x ULN on at least 1 previous occasion within the past 6 months and at Pre-treatment visit 6. alpha-fetoprotein (AFP) less than/equal to 50µg/L 7. Hemoglobin ≥100g/L, platelet count ≥75x109/L, and white blood cell count ≥1.5x109/L 8. Males, or females who are not of child-bearing potential or who are taking adequate contraceptive measures. Female patients must be postmenopausal for at least 2 years prior to the study, surgically sterile, or using effective contraception for at least 2 months prior to starting study drug and until 28 days following the last dose of study drug. Acceptable methods of birth control hormonal contraceptives, or double-barrier methods.Negative serum pregnancy test must be documented at the Pre-treatment visit (i.e. within 14 days of starting study drug) 9. Liver biopsy within past 3 years showing stage 2 fibrosis only (i.e. excludes cirrhosis and cancer); or within past 6 years showing stage 0 or 1 (no or minimal scarring) Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques) 2. Presence of human immunodeficiency virus (HIV) 3. Co-infection with hepatitis B virus (HBV) 4. Last baseline AST and ALT level prior to Day 1 of <2.0xULN 5. Renal impairment (creatinine>1.5 x ULN) or hepatorenal syndrome 6. Chronic pancreatitis 7. Hospitalization for liver disease within 60 days of the Pre-treatment visit 8. Liver transplant recipients 9. Use of drug therapy for Hepatitis C, including the use of: 1. drugs with presumed anti-Hepatitis C activity in the past 3 months 2. corticosteroids in the past 30 days 3. drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days 10. Any patient who admits to using or has a positive screening test for: amphetamines, barbiturates, pethidine, benzodiazepine, cocaine, methadone, opiates, phencyclidine or propoxyphene (unless medically prescribed and in stable doses for at least 30 days) 11. Alcohol consumption >5 units per week 12. Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial 13. History of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded 14. Use of antioxidants (Coenzyme Q10 and idebenone) at doses ≥300mg/day within 120 days prior to enrolment. Doses between 25-300mg/day are not an and require a 7 day washout prior to study enrolment 15. Use of dietary supplements (vitamin or mineral) at constant doses throughout the study (unless medically prescribed). Patients choosing to stop using supplements are not excluded and require a 7 day washout period prior to study enrolment 16. History of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone 17. Unable to swallow tablets whole
|
0
|
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.
|
eligible ages (years): 14.0-999.0, Unspecified Adult Solid Tumor, Protocol Specific Histologically or cytologically confirmed malignant solid tumor Refractory disease for which curative or palliative measures have failed or for which there is no known superior treatment No colorectal cancer or melanoma Measurable OR nonmeasurable disease Normotensive (blood pressure [BP] ≤ 140/90 mm Hg) meeting 1 of the following No more than 2 attempted measurement sessions for which the documented mean systolic BP is ≤ 140 mm Hg and the diastolic BP is ≤ 90 mm Hg At least 30 attempted measurement sessions for which the documented mean systolic BP is ≤ 135 mm HG and the diastolic BP is ≤ 85 mm Hg Brain metastases allowed provided the following are met Stable neurologic status for ≥ 2 weeks after completion of definitive local therapy (surgery or radiotherapy) No neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Venous Thrombosis Pulmonary Embolism Age 19-65 years 2. BMI 35-65 Kg/m2 3. Pregnancy test Negative on day of study 4. Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents. 1. BP ≥ 160/90 2. Temperature > 37.5 0C (99.5 0F) 3. Nursing mothers if nursing 4. Pregnancy test Positive on day of study 5. Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study Past medical history 1. cerebrovascular accident (including TIA within 6 months of the study) 2. Diabetic retinopathy proven by fundoscopy 3. History of inherited thrombotic/hypercoagulable defect 4. Active peptic ulcer disease diagnosed by upper endoscopy 5. Known bleeding disorder, thrombophilia 6. History of heparin induced thrombocytopenia 7. History of bacterial endocarditis 8. Known hypersensitivity to fondaparinux 9. Ulcerative colitis 10. History of GI bleeding 11. History of hematuria 12. Recent surgery (last 3 months) 13. Recent trauma (last 3 months) Laboratory values 1. Platelet count ≤ 100,000 mm3 2. Hemoglobin < 12 g/dL (women), or < 14 g/dL (men) 3. Prothrombin time > 13 sec 4. PTT > 35 sec 5. ALT 3xULN and bilirubin 1.5xULN (>35% direct); or ALT 5xULN; or ALT 3xULN if associated with the appearance or worsening of hepatitis symptoms or rash 6. Estimated urinary creatinine clearance ≤ 50 ml/min 7. Hematuria on urine dipstick
|
1
|
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.
|
eligible ages (years): 18.0-65.0, HIV Infections Hepatitis C Subject is >18 years old Subject has given written informed consent Subject has a confirmed diagnosis of HIV and HCV infection Subject is naive for HCV-infection treatment Subject has chronic hepatitis and/or subject has compensated cirrhosis (Child class A) Subject has a CD4+ count of > 350 cell/mmc Subject is HIV-RNA negative during the previous six month Subject is on stable HAART including r/LPV for > 6 months Subject has genotype available at baseline and no mutations associated with resistance to PI or no virologic failure on PI treatment, defined as a confirmed HIV-RNA level>50 cp/mL after 24 weeks, > 50 cp/ml after 48 weeks, or a repeated HIV RNA level > 50 cp/mL after prior suppression of viremia to< 50 cps/mL Free of any clinically significant disease (other than HIV and HCV) that would interfere with study evaluations Subject is HbsAg positive Subject has cirrhosis score Child-Pugh B/C No previous hepatic decompensation Subject has HIV-related thrombocytopenia (Platelets count < 50.000/mmc) Subject has neutrophils count < 1500/mmc Subject has Hb value < 11 g/dL Subject has creatinine value > 1.5 mg/dL Subject is pregnant or wishes to become so Subject has any cause of liver disease other than chronic hepatitis C, status of liver decompensation or any other condition consistent with decompensated liver disease (bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy) Subject is alcohol abuser (> 30 gr/die)
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Subject To be eligible for enrollment, patients must meet all of the following 1. At least 18 years of age 2. Diagnosed with compensated chronic HCV genotype 1 infection that has not been treated with interferon, peginterferon, ribavirin or any experimental therapy for >28 days 2a Serum HCV RNA >2000 copies/mL (780 IU/mL) 2b Liver biopsy performed within 3 years prior to screening consistent with chronic HCV infection 2c for compensated HCV infection, including normal prothrombin time, serum albumin and bilirubin levels (unless due to non-hepatitis factors) and no history or evidence of bleeding esophageal varices, ascites, or hepatic encephalopathy 3 History of alanine aminotransferase (ALT) elevation either within 6 months prior to screening, at screening, or on retest 2 weeks after a negative screening test, or histologic evidence of HCV infection and a detectable viral load 4 Platelet count ≥90,000/mm3 5 Absolute neutrophil count ≥1200/mm3 6 Hemoglobin ≥12.0 g/dL for females or ≥13.0 g/dL for males 7 Antinuclear antibody (ANA) titer ≤1:320 8 Serum creatinine <1.5 mg/dL 9 HbA1c ≤8.5% for diabetic patients 10 Normal or adequately controlled TSH on prescription medication 11 Alpha fetoprotein (AFP) <20 ng/mL or hepatocellular carcinoma ruled out (ultrasound, CT or MRI scan) within 6 months prior to the study (Patients with an AFP >20 ng/mL must have ongoing hepatocellular carcinoma screening during study as part of the patient's routine medical care) 12 All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator 13 Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose 14 Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent Subject Patients who have any of the following during the screening or Day 1 visit are not eligible for enrollment in this study: 1. Positive HIV or HbsAg serology 2. Severe psychiatric or neuropsychiatric disorders including severe depression, history of suicidal ideations or suicide attempt(s). (This would patients with a history of suicidal ideations or suicide attempt(s) that occurred when the patient was a minor or many years ago; if the event occurred while under the influence of alcohol or drugs; if the suicidal ideations or suicide attempt(s) were connected to a traumatic event; if the patient was not hospitalized or treated; if the patient has obtained psychiatric clearance for treatment) 3. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease 4. History of thalassemia or other hemoglobinopathies (even if the hemoglobin is normal) 5. Chronic hepatic disease other than hepatitis C 6. Organ or bone marrow transplant 7. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study 8. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study 9. Males whose female partners are pregnant 10. Patients who have had a malignancy diagnosed and/or treated within the past 5 years, except for localized squamous or basal cell cancers treated by local excision 11. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening 12. History of alcoholism or drug addiction 1 year prior to screening 13. The use of methadone, buprenorphine or any similar drug, regardless of the prescribed indication or the length of time the patient has been on the drug 14. Chronic (>4 weeks duration) diarrhea, including irritable bowel disease 15. Fibrosis score F4 (cirrhosis) based on Metavir or equivalent index 16. Weight >128 kg or <40 kg 17. Patients infected with mixed HCV genotypes
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Hepatitis C Hepatitis C HIV positivity
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Hepatitis C Part I and Part II: 1. Informed consent obtained and signed; 2. Male or female patients, age 18-65 years old (inclusive) 3. Female patients will be menopausal for at least 12 months, surgically sterile or agree not to become pregnant from the time of study enrollment until at least 28 days after the administration of vaccine or placebo. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. If the volunteer is female, of childbearing potential, and sexually active, she agrees to use acceptable contraception. (Acceptable contraception methods are restricted to effective intrauterine devices (IUDs) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination and for the entire study period post-vaccination). Note: A woman is eligible if she is monogamous with a vasectomized male or abstinent, without the additional need for hormonal or barrier birth control methods upon review of a reproductive history. 4. With chronic hepatitis C evidenced by HCV RNA detectable in blood, and A liver biopsy compatible with chronic hepatitis C; 5. Infected with HCV genotype 1; 6. Non-cirrhotic patients, i.e. liver biopsy available within one year prior to baseline, excluding stage 4 fibrosis; otherwise, if no liver biopsy of less than one year is available, it will be performed at baseline; 7. Patients participating in Part I will be non-responder patients: patients having received at least 3 months of pegylated IFN-alpha (IFN-alpha) plus ribavirin, with currently detectable HCV RNA (whether or not they reach, Early Virologic Response (EVR, defined as a reduction of HCV RNA by at least 2 logs from baseline or negative at 12 weeks) and/or SVR) with > 6 months between the end of PEG IFN-alpha treatment and the first TG4040 injection Part IIa will be either non-responder or relapser patients. Part IIb will be treatment-naïve patients: patients who have never received IFN-based treatment 8. Patients must have compensated liver disease, defined through use of the Child-Pugh scoring system with Features of low serum albumin, prolonged prothrombin time, raised bilirubin, ascites and hepatic encephalopathy are scored and patients assigned to Child-Pugh class A, B or C, the later two being decompensated. Only patients with compensated liver disease will be enrolled No history of ascites, hepatic encephalopathy or bleeding from esophageal varices laboratory tests values Serum bilirubin and international normalized ratio (INR) values <1.2 (except in patients with Gilbert syndrome where serum bilirubin may be as high as 3.0 mg/dL) Serum alanine aminotransferase (ALT) < 5 fold the upper limits of normal (ULN) and Other laboratory parameters of grade 0 or 1 (CTC criteria) Part I and Part II: 1. Co-infection with HBV (indicated by the presence of hepatitis B surface antigen (HBsAg) in serum) or HIV (anti-HIV in serum); patients with HIV positive sexual partner (by history) will not be included; 2. Current HCV therapies through out the trial period 3. Current alcohol abuse or drug addiction that in the opinion of the investigator may interfere with the subject's ability to comply with trial procedures. 4. History of immunodeficiency 5. Known or suspected impairment of immunologic function including moderate to severe kidney impairment 6. Malignancy within the last 5 years, not including squamous cell skin cancer or basal cell skin cancer unless at the vaccination site or history of skin cancer at the vaccination site 7. Significant cardiac disease, evidenced by History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath on activity, or other heart conditions under the care of a physician Baseline ECG showing clinically significant abnormalities (e.g., all kinds of advanced atrioventricular block or intraventricular block with QRS >120msec, QTc >460 msec, or frequent premature atrial contractions, atrial fibrillation or other atrial arrhythmias, > ventricular couplets or ST-T wave abnormalities diagnostic of myocardial ischemia or prior myocardial infarction. EKGs will be interpreted by an identified cardiologist at Saint Louis University prior to enrollment Baseline echocardiogram showing clinically significant abnormalities including valvular disease or contractile dysfunction Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp) NOTE: This criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply: A) have smoked a cigarette in the past month, and/or B) have hypertension (defined as systolic blood pressure >140 mm Hg) or are on antihypertensive medication, and/or C) have a family history of coronary heart disease in male first-degree relative (father or brother) < 55 years of age or a female first-degree relative (mother or sister) < 65 years of age. 8. Current use of immunosuppressive medication; Corticosteroid nasal sprays, Inhaled steroids for asthma and/or topical steroids are permissible. Persons taking short courses of oral steroids for conditions such as poison ivy will need to wait a period of 2 weeks after completion of the steroids to begin vaccination. 9. History of any one of the following Suicide attempt or hospitalization for depression within the past five years Any current (within 6 months) severe or poorly-controlled psychiatric disorder (e.g., depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, personality disorder) The following patients must be excluded unless they are assessed and followed by a psychiatrist or other mental health professional who pre-approves their study participation Patients who have had a suicide attempt and/or hospitalization for depression more than 5 years ago Patients who have had a severe or poorly-controlled psychiatric disorder (e.g., depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, personality disorder) more than 6 months ago but less than 5 years ago. 10. Receipt of any inactivated vaccine 14 days prior to vaccination or for the duration of the study 11. Receipt of any live attenuated vaccine within 30 days prior to vaccination or for the duration of the study 12. Receipt of any MVA vaccine in the last five years 13. Use of any experimental agent within 30 days prior to vaccination or for the duration of the study 14. Receipt of blood products or immunoglobulin within six months prior to vaccination 15. Donation of a unit of blood within 56 days prior to vaccination or for the duration of the study following the first vaccination 16. Acute febrile illness (>100.5 degrees F) on the day of vaccination 17. Pregnant or lactating women 18. Any condition that, in the opinion of the investigator, might interfere with study objectives 19. Known allergy to MVA vaccine 20. Receipt of antiviral drugs such as alpha interferon or ribavirin 21. Other laboratory parameters of grade 2 or more 22. Study personnel engaged in the blinding of this study
|
1
|
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.
|
eligible ages (years): 18.0-70.0, Chronic Hepatitis C Hepatic Fibrosis Age older than 18 years HCV RNA and anti-HCV positivity for more than 6 months consecutive normal ALT values (< 40 IU/L for men and < 34 IU/L for women)at 3 months apart over a period of 12 months HBV and HCV co-infection HBV and HIV co-infection History of heavy alcohol use (> 50 gram/day) Autoimmune liver diseases Metabolic liver diseases Presence of hepatocellular carcinoma Bleeding tendency Decline liver biopsies
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Chronic Hepatitis C Hepatic Fibrosis Cirrhosis Age older than 18 years Positive anti-HCV and HCV RNA for more than 6 months Alanine aminotransferase level more than twice the upper limit of normal (ULN) HBV and HCV co-infection HIV and HCV co-infection Heavy alcohol use (> 50 gram/day) Autoimmune liver diseases Metabolic liver diseases Presence of hepatocellular carcinoma
|
0
|
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.
|
eligible ages (years): 18.0-999.0, HIV Infections HCV Age greater than or equal to 18 years. 2. Documentation of HIV-1 infection by licensed ELISA test and confirmed by a Western Blot. 3. Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of 2000 copies/mL or greater. 4. Histopathologic features consistent with chronic hepatitis C at the time of enrollment. A liver biopsy done for a subject within 24 months prior to his or her participation may be used as the baseline biopsy. 5. Patients infected with genotype 1. 6. Patients with CD4+ cell counts greater than 100 cells/mm(3). 7. Ability to sign the Informed Consent document, and willingness to comply with the study requirements and clinic policies. 8. Neutrophil count greater than 1000 cells/mm(3). 9. Platelets greater than 75,000/mm(3). 10. Hemoglobin greater than 10.5 g/dL. 11. ALT less than 7 times the NIH upper limit of normal. 12. Serum lipase less than 1.5 times the NIH upper limit of normal. 13. Not pregnant or breast-feeding. 14. If the patient is able to become pregnant, then she must use two 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. 15. Willingness to not become pregnant until 7 months after completion of ribavirin therapy. 16. Male subjects 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 7 months after their last dose of ribavirin. 17. Patients with a documented addiction are currently in an addiction-free period for at least 6 months and in the clinical judgment of the investigator are not at risk of relapse. 18. Opioid-dependent patients are in a supervised methadone treatment program. 19. Need to have a primary doctor outside of OP8 or as part of the OP8 training clinic who will be taking care of the patients for their HIV infection and liver disease. 20. Willing to designate a person for durable power of attorney on the NIH form for medical research and medical care purposes at the NIH Clinical Center. 21. Able to learn to safely inject medication Alb-IFN subcutaneously or be able to find another person or a clinic to inject the medication for him/her. 22. Willingness to abstain from alcohol use during the trial. 23. Willingness to allow stored blood or tissue samples to be used in the future for studying HIV disease and immune function. 24. Willingness to permit HLA typing to be performed Patient cannot be on other experimental therapies (including expanded access/compassionate use of antiretrovirals) during his/her participation in this protocol. 2. Patients cannot have used interferon or peginterferon previously for the treatment of hepatitis C. 3. Mixed genotypes (e.g., 1/2, 1/4). Mixed genotype 1a/1b will be enrolled. 4. Liver histology which, in the opinion of Clinical Center pathologist, is consistent with any other co-existent cause of chronic liver disease as defined as: chronic hepatitis B with positive HBsAg autoimmune hepatitis with a positive ANA greater than 1 unit or positive anti mitochondrial antibody greater than 1 unit; cholestatic disease with persistent elevation of alkaline phosphatase; primary biliary cirrhosis or sclerosing cholangitis; Wilson's disease; alpha-1-antitrypsin deficiency; steatohepatitis (alcoholic or non alcoholic) with marked steatosis, many Mallory bodies, or extensive zone 3 periportal fibrosis. 5. Hemochromatosis or secondary iron overload as defined by (1) an elevated serum ferritin or an iron saturation (serum iron/IBC times 100%) of greater than 50%, and (2) presence of 3+ or more stainable iron on liver biopsy according to the study pathologist. Those subjects with, or a history of previous phlebotomy for iron overload will undergo HFE genetic counseling and those with a positive HFE genetic test demonstrating homozygosity for C282Y and H63D are not eligible. Those who have compound heterozygosity to C282Y and H63D are also not eligible. 6. For patients with cirrhosis, a Child Turcotte Pugh score greater than 7. 7. PT-INR greater than 2 or history of hemophilia or known history of Vitamin K deficiency or use of anticoagulants. 8. Organ transplant recipient other than cornea or hair transplant. 9. Estimated Creatinine clearance (eGFR) less than 50 mL/min. 10. A serum alpha-fetoprotein level (greater than 20 ng/mL, unless the subject has a negative ultrasound before enrollment. 11. For patients with history of diabetes mellitus, a HbA1C less than or equal to 7.5% and for those with a fasting blood glucose level of greater than 140mg/dL, a HbA1C of less than or equal to 7.5%. 12. Coexisting neoplastic disease except for Kaposi's sarcoma, any non-metastatic skin cancer that has been resected, or non-metastatic cervical or anal cancer that has been resected. 13. Severe cardiac disease (Grade 3 or more congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, uncontrolled hypertension). 14. Severe chronic pulmonary disease with functional impairment or a DLCO less than or equal to 50% at baseline. 15. Severe psychiatric disorder that would interfere with the adherence to protocol requirements. 16. Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis. 17. Preexisting uncontrolled seizure disorder defined as one episode of seizure within the past 2 years. 18. Chronic pancreatitis. 19. Severe retinopathy as determined by the ophthalmologist. 20. Hemoglobinopathy (e.g., Thalassemia, sickle cell disease). 21. Currently taking didanosine or d4T as part of antiretroviral regimen. 22. Direct bilirubin greater than or equal to 0.6 mg/dL. 23. Concurrent use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of greater than 10 mg/day) for a duration of six weeks or more within six months prior to enrollment. 24. Concurrent use of fluticasone and high dose ritonavir (600mg t.i.d). 25. Chronic viral hepatitis of any other etiology other than hepatitis C. 26. Active systemic infections other than hepatitis C and HIV. 27. Liver disease caused by reasons other than hepatitis C, like HBV, HDV, Wilson's disease, hemochromatosis, autoimmune hepatitis (ANA greater than 1 unit) except history of drug-associated hepatitis with discontinuation of the causative agent. 28. Hepatic mass suggestive of hepatocellular carcinoma as detected by ultrasound scan. 29. Alcohol or substance abuse within the past 6 months that potentially could interfere with patient compliance. 30. Concomitant use of amphetamines, barbiturates, cocaine, ganciclovir, isoniazid, opiates, pyrazinamide, rifabutin, rifampin/rifampicin, thalidomide, and theophylline. 31. History of esophageal varices. 32. Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits. 33. Evidence of gastrointestinal malabsorption, chronic nausea, or vomiting. 34. Male partners of pregnant women. 35. Pregnant women. 36. Breastfeeding women. 37. Hypersensitivity to interferon products or ribavirin. 38. Received silymarin (milk thistle) or glycyrrhizin within 28 days prior to Day 0. 39. Received Sho-saiko-to (SST) within 28 days prior to Day 0. 40. Received any other experimental agent within 28 days prior to Day 0
|
1
|
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.
|
eligible ages (years): 18.0-50.0, Hepatitis C Chronic Disease Treatment Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age) Treatment naïve patients Serological evidence of hepatitis C infection by an anti-HCV antibody test HCV PCR positive Genotype 3 Absence of cirrhosis on liver biopsy Absence of alcohol or drug abuse Patients who do not consent to be included in the study Pregnant or breast feeding females Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm Genotype non 3 HCV PCR positive at the end of 4 weeks of treatment Presence of cirrhosis on liver biopsy Decompensated liver disease History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure) History of having received IFN, PEG-IFN, RBV therapy previously History of systemic antiviral therapy or investigational drug 3 months prior to the first dose of study treatment
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Hepatitis C HCV RNA: Positive Biopsy approved in genotype 1 Age older than 18 yrs ongoing pregnancy or breast feeding Hx of hemochromatosis Hx of metabolic liver dis Hx of HCC Hx of autoimmune hepatitis Hx of alcoholic liver dis Hx of bleeding from esophageal varices ongoing systemic anti-viral or anti-neoplasmic treatment Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C Chronic genotype 1 Hepatitis (inflammation of the liver) C infection Never been treated for Hepatitis C Viral (HCV) infection No clinically significant lab abnormalities Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years Contra-indications for starting anti-HCV therapy History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease Any evidence of significant liver disease in addition to Hepatitis C Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
|
1
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C HIV Infections Male and female patients between 18 and 65 years of age Anti-HCV positive Detectable plasma HCV-RNA Relapsers after treatment with interferon o peginterferon +/ ribavirin HIV positive CD4 >/= 200 cell Patients on clinically stable liver disease with Hgb >/= 12 g/dL in women or 13 g/dL in men Leucocytes >/= 3000 mm3 Women with ongoing pregnancy or breast feeding Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg Hemochromatosis Deficit of alfa-1 antitrypsin Wilson disease Alcoholic liver disease Autoimmune hepatitis Hepatitis by toxin exposures Hepatitis by obesity Hemoglobinopathy (e.g. thalassemia)
|
0
|
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.
|
eligible ages (years): 18.0-70.0, Hepatitis C Genotype 3 Non-responders Relapsers Non-responders and relapsers to previous interferon and ribavirin therapy given for six months HCV genotype 3 Compensated liver disease Hb ≥10 g/dl (females),≥11 g/dl (males) Platelets count ≥ 100,000 / cubic mm Neutrophils count ≥1,500/cubic mm ≥18 years to ≤ 70 years At least one abnormal ALT value in the last year TSH level within normal limits Non pregnant adult females Patient younger than 18 yrs and older than 70 yrs Hepatitis B or HIV co-infection Severe renal dysfunction or creatinine clearance less than 50 ml/min Pregnant women or breast feeding women Suspected hypersensitivity to Interferon alpha, gamma or ribavirin Decompensated liver cirrhosis History or any other evidence of other causes of CLD other than hepatitis C infection ( like hemochromatosis,, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, Wilson's disease,Drug induced liver disease) Active malignant disease Any known pre-existing medical condition that could interfere with subject's participation or completion of study such as psychiatric condition, seizures disorder requiring medications, co existing heart diseases, lung diseases, poorly controlled diabetes, auto immune diseases, gout) History of interferon and/or ribavirin intolerance
|
2
|
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.
|
eligible ages (years): 18.0-49.0, Chronic Hepatitis C Key Chronically infected with hepatitis C virus genotype 1 Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus Hepatitis C virus RNA viral load of ≥ 10*5* IU/mL BMI 18 to 35 kg/m² Key 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 Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
|
2
|
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.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis C Diagnosis of chronic hepatitis C Non-response to or relapse from primary standard HCV therapy HLA A2 positive HCV-RNA positive HCV antibodies positive Liver biopsy within 30 months prior to Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal) Male and female From 18 to 65 years Written informed consent obtained prior to study entry Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see 2: The Ishak Modified Hepatic Activity Index (HAI)) Any liver disease other than hepatitis C History of autoimmune disease Immunodeficiency including post-organ-transplantation HIV infection Immunosuppressive therapy Any acute infections within 4 weeks prior to History of severe hypersensitivity reactions, anaphylaxis or atopy Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
|
2
|
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.
|
eligible ages (years): 18.0-999.0, Alcoholic Liver Disease Chronic Hepatitis C Virus Alcohol excess intake and suspected liver disease Alcohol excess intake and clinical liver cirrhosis chronic hepatitis C virus infection and suspected liver disease chronic hepatitis C virus infection and clinical liver cirrhosis bacterial or fungal infection immunosuppressive treatment other causes of liver disease
|
0
|
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.
|
eligible ages (years): 0.0-999.0, Hepatitis C Virus Infection Chronic Liver Disease Anti-HCV-positive patients Anti-HCV-negative patients
|
2
|
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.
|
eligible ages (years): 18.0-80.0, Chronic Hepatitis C Neoplasms Male and female patients >18 years of age Local or Systemic malignancy other than hepatocellular carcinoma in remission or stable status Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test Detectable serum HCV-RNA Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.) Compensated liver disease (Child-Pugh Grade A clinical classification) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end Women with ongoing pregnancy or breast feeding Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug Any investigational drug 6 weeks prior to the first dose of study drug Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV) 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) Clinical evidence of hepatocellular carcinoma 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 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
|
1
|
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.
|
eligible ages (years): 18.0-65.0, Hepatitis C Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug Participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug Participant has a clinical diagnosis of chronic HCV infection (for Part II only) Participant has a history of stroke, chronic seizures, or major neurological disorder Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases Participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment Participant has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit Participant has a history of documented Human Immunodeficiency Virus (HIV) infection
|
2
|
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.
|
eligible ages (years): 18.0-75.0, Hepatitis C Health insurance Resolved HCV infection ( HCV RNA negative since more then 6 months ) -HCV chronically infected ( RNA positive ) Anti HCV antibodies positive Volunteers and informed patients Immunosuppression HBV or HIV infection Pregnancy Breast feeding
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Liver Transplantation Liver transplantation performed for non-autoimmune liver disease performed at least 3 years before IS weaning Absence of acute and/or chronic rejection episodes during the 12 months before weaning Basal liver biopsy without signs of acute and/or chronic rejection No evidences of autoimmune liver disease Absence of acute and/or chronic rejection episodes during the 12 months before weaning Basal liver biopsy without signs of acute and/or chronic rejection Low dose immunosuppression (monotherapy with calcineurin inhibitors, mTOR inhibitors or mycophenolate mofetil, or combined therapy with 2 drugs at very low doses) Absence of medical or psychological disturbances that preclude the safe performance of the trial Stability of liver graft function, defined as: normal liver function tests (AST, ALT, ALP, GGT) during at least 6 months, or, alternatively, minor alterations in liver function tests that have not changed over the previous 6 months (AST/ALT < 2 fold normal levels; ALP < 1.5 fold normal levels; GGT < 2 fold normal levels; bilirubin < 2 mg/dL) Patients exhibiting at least one of the following characteristics: a) severe side effects of immunosuppressive drugs (diabetes, renal failure, hyperlipidemia, hypertension); b) risk of neoplasm development defined by history of previous non-hepatocarcinoma neoplasms or history of any of the following risk factors: tobacco or alcohol consumption, age greater than 60 years; c) chronic liver disease due to hepatitis C virus infection in patients not receiving anti-viral treatment
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.