At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
In Brief
A Phase 2 clinical trial evaluating Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN), and 2 other interventions for Hepatitis C. Completed, enrolled 95 participants.
Detailed Summary
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Study Details
Timeline
Interventions
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Matching placebo to vaniprevir; duration of treatment: 28 days