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)

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.