NCT01370642

Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	vaniprevir	Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
DRUG	Placebo to vaniprevir	Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
BIOLOGICAL	Peg-IFN	Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
DRUG	ribavirin	Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Timeline

• Start date: 2011-06-27
• Primary completion: 2013-07-31
• Completion: 2014-03-17
• First posted: 2011-06-10
• Last updated: 2018-10-18
• Results posted: 2014-10-06