NCT01390844

Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Boceprevir (BOC)	200 mg capsules, 800 mg three times daily by mouth
DRUG	Placebo to boceprevir	200 mg placebo capsules, 800 mg three times daily by mouth
DRUG	Peginterferon alfa-2b (PEG)	1.5 mcg/kg/week subcutaneously
DRUG	Ribavirin (RBV)	200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
DRUG	Cross-Over Boceprevir Treatment	At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Timeline

• Start date: 2011-10-21
• Primary completion: 2015-06-19
• Completion: 2015-06-19
• First posted: 2011-07-11
• Last updated: 2018-09-11
• Results posted: 2016-06-28