Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 737
Healthy volunteers: no

Brief summary:
This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (\>) 500 individuals.

Detailed description:

Arms:
arm 1: Participants will receive PEG-IFN (180 microgram \[mcg\]), subcutaneously (sc), once weekly for 24 weeks and Ribavirin 1000-1200 milligram per day (mg/day) (\<75 kilogram (kg); \>75 kg) for 24 weeks. arm 2: Participants will receive PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) till week 24; if patient is still HCV RNA positive. Treatment will be stopped if participant is HCV RNA negative at week 24 -treatment with PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) till week 72 arm 3: Participants will receive PEG-IFN (180 mcg), sc, once weekly for 48 weeks and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) for 48 weeks. arm 4: Participants will receive PEG-IFN (180 mcg), sc, once weekly for 72 weeks and Ribavirin 1000-1200 mg/day (\<75 kg; \> 75 kg) for 72 weeks.

Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\\n intervention 2: Ribavirin is available as 200 mg tablets

Protocol document: