Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

Detailed description:

Arms:
arm 1: Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. arm 2: Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.

Interventions: intervention 1: Peginterferon alfa-2b (PegIFN-2b) intervention 2: Comparator: Stronger neo minophagen C (SNMC)
Intervention descriptions: intervention 1: PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks intervention 2: SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

Protocol document: