Conditions: Hepatitis C, Chronic Liver Cirrhosis
Keywords: hepatitis C
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Peginterferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: Administered at 1.0 µg/kg/week SC for 48 weeks intervention 2: Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL; treatment duration is 48 weeks

Protocol document: