efficacy of polyethylene glycol-interferon alfa-2b (peg-intron, sch 54031) compared to interferon alfa-2b in participants with chronic hepatitis c (mk-4031-016)

Conditions: Hepatitis C

Summary: this study will determine the efficacy of peg-intron (sch 54031) in participants with chronic hepatitis c virus (hcv) infection who have not been previously treated with interferon. participants are randomized to receive one of three doses of peg-intron (0.5, 1.0, and 1.5 mg/kg) or interferon alfa-2b for 48 weeks. the primary objective of this study is to evaluate the efficacy of peg-intron (compared to interferon alfa-2b) with respect to response based on loss of detectable hcv ribonucleic acid (hcv-rna) and normalization of alanine transaminase (alt) level after 24 weeks of therapy and at 24 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * be serum positive for hepatitis c virus. * have liver biopsy within 1 year prior to entry, with a pathology report confirming a histological diagnosis consistent with chronic hepatitis. * have one abnormal historic alt at least 6 months prior to screening, with elevated alt at entry. * have compensated liver disease, testing negative for hiv and serum hepatitis b surface antigen (hbsag) at entry. * if male or female of childbearing potential, be practicing adequate contraception during treatment. exclusion criteria: * be female who is currently pregnant or nursing. * have prior treatment with any interferon. * have suspected hypersensitivity to alpha interferon. * have participated in any other clinical trial within 30 days of entry * have received treatment with any investigational drug within 30 days of entry. * have received prior treatment for hepatitis with any other antiviral or immunomodulatory drug within the previous 2 years. * have any other cause for the liver disease other than chronic hepatitis c including but not limited to: co-infection with hepatitis b virus; hemochromatosis; alpha-1 antitrypsin deficiency; wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease; and drug-related liver disease. * have hemophilia or any other condition that would prevent the participant from having a liver biopsy, including anticoagulant therapy. * have hemoglobinopathies (e.g., thalassemia) * have evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy. * have received organ transplants. * have a preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or attempt. * have central nervous system trauma or active seizure disorders requiring medication. * have significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia). * have poorly controlled diabetes mellitus. * have chronic pulmonary disease (e.g., chronic obstructive pulmonary disease). * have immunologically mediated disease (e.g., inflammatory bowel disease \[crohn's disease, ulcerative colitis\], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis). * have any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. * have history of substance abuse, such as alcohol, intravenous drugs and inhaled drugs. * have clinically significant retinal abnormalities. * be unable to abstain from the consumption of alcohol. * have any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol.