Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

Inclusion Criteria:

• Age at entry 18-65 years;
• Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
• Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

• Any other cause for liver disease other than chronic hepatitis C;
• History or presence of complications of cirrhosis;
• Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
• Diseases or conditions that could interfere with participation in the study