At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating vaniprevir, Placebo to vaniprevir, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 294 participants.
Detailed 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.
Study Details
Timeline
Interventions
Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
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