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Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
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.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | Fri Jul 25 2008 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Apr 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hepatitis C
Interventions
- Comparator: Vaniprevir
- Comparator: Pegylated-Interferon (Peg-IFN)
- Comparator: Ribavirin
- Comparator: placebo