At a glance
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A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment
In Brief
A Phase 3 clinical trial evaluating vaniprevir, peg-IFN, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 51 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 (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. 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 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).
Study Details
Timeline
Interventions
vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks
Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks