Conditions: Hepatitis C, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 129
Healthy volunteers: no

Brief summary:
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: peginterferon alfa-2a intervention 2: ribavirin [Copegus]
Intervention descriptions: intervention 1: 180 mcg sc weekly, 48 weeks intervention 2: 1'000 or 1'200 mg orally daily, 48 weeks

Protocol document: