Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
Healthy volunteers: no

Brief summary:
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Detailed description:

Arms:
arm 1: Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W). arm 2: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W. arm 3: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W. arm 4: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.

Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: ribavirin intervention 4: ribavirin
Intervention descriptions: intervention 1: 180 mcg sc weekly, 24 weeks intervention 2: 180 mcg sc weekly, 16 weeks intervention 3: 800 mg orally daily intervention 4: 400 mg orally daily

Protocol document: