NCT01544920

Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 737 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele. The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	peg-Interferon alfa-2a	peg-IFN (180 ug) was taken once weekly via subcutaneous injection.
DRUG	Ribavirin	RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight \<75 kilograms \[kg\]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings.
DRUG	Boceprevir	Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.

Timeline

• Start date: 2012-05-30
• Primary completion: 2015-05-19
• Completion: 2015-05-19
• First posted: 2012-03-06
• Last updated: 2018-09-11
• Results posted: 2016-05-30