Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa-

2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the

addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with

peginterferon alfa-2a/ribavirin.

Detailed description:

Arms:
arm 1: Peginterferon alfa-2a (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + peginterferon alfa-2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up. arm 2: Peginterferon alfa-2a (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by boceprevir (800 mg three times a day \[TID\] PO, using SCH 503034 200-mg capsules) + peginterferon alfa-2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks

with 24 weeks post-treatment follow-up.

Interventions: intervention 1: Boceprevir intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: 800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 2: 800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 3: Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks intervention 4: Ribavirin 200-mg capsules, weight-based dosing

* \<75 kg, 1000 mg/day orally (PO), divided twice daily (BID)
* \>=75 kg, 1200 mg/day PO, divided BID

for 48 weeks

Protocol document: