NCT00845065

Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Boceprevir	800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
OTHER	Placebo	800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
BIOLOGICAL	Peginterferon alfa-2a	Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks
DRUG	Ribavirin	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

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-02-16
• Last updated: 2017-04-07
• Results posted: 2012-02-02