drugset / Trial / 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)

NCT00845065

Phase 3 Completed 202 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-02
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Boceprevir Small molecule 800 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral