Conditions: Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 2333
Healthy volunteers: no

Brief summary:
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: REBETOL (ribavirin; SCH 18908)
Intervention descriptions: intervention 1: PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks intervention 2: REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Protocol document: