At a glance
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A Phase 3 Safety and Efficacy Study of Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
In Brief
A Phase 3 clinical trial evaluating Boceprevir, Placebo, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 202 participants.
Detailed 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.
Study Details
Timeline
Interventions
800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks
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