Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 165
Healthy volunteers: no

Brief summary:
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: boceprevir intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: ribavirin (Copegus] intervention 5: ribavirin (Copegus]
Intervention descriptions: intervention 1: 800 mg three times daily for 24, 32 or 44 weeks intervention 2: 180 mcg subcutaneously once a week for 24, 32 or 44 weeks intervention 3: 180 mcg subcutaneously once a week for 4 weeks intervention 4: 1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks intervention 5: 1000 mg or 1200 mg orally once a day for 4 weeks

Protocol document: