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

PHASE3CompletedINTERVENTIONAL
Enrollment

282

Participants

Timeline

Start Date

October 21, 2011

Primary Completion Date

June 19, 2015

Study Completion Date

June 19, 2015

Conditions
Hepatitis C, Chronic
Interventions
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.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01390844 - Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063) | Biotech Hunter | Biotech Hunter