Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

Brief summary:
The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.

Detailed description:

Arms:
arm 1: Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.

Interventions: intervention 1: Pegylated Interferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks intervention 2: Ribavirin 400 mg/day orally

Protocol document: