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, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
In Brief
A Phase 2 clinical trial evaluating Vaniprevir, Pegylated Interferon (Peg-IFN), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 285 participants.
Detailed Summary
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).
Study Details
Timeline
Interventions
Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.
Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.
Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.