A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
Summary
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.
Timeline
- Start
- 2009-04-20
- Primary completion
- 2010-06-03
- Completion
- 2012-02-23
Outcome
Met primary endpoint
paper Rates of RVR were significantly higher with vaniprevir compared with placebo PMID 25115901 ↗
registry analysis (superiority or other test); Vaniprevir 200 mg + Peg-IFN + Ribavirin vs Placebo + Peg-IFN + Ribavirin; p <0.001 NCT00880763 ↗
registry analysis (superiority or other test); Vaniprevir 600 mg + Peg-IFN + Ribavirin vs Placebo + Peg-IFN + Ribavirin; p <0.001 NCT00880763 ↗
registry analysis (superiority or other test); Vaniprevir 1200 mg + Peg-IFN + Ribavirin vs Placebo + Peg-IFN + Ribavirin; p <0.001 NCT00880763 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vaniprevir | Small molecule | 100 mg | Oral |
| Subject | Vaniprevir | Small molecule | 300 mg | Oral |
| Subject | Vaniprevir | Small molecule | 600 mg | Oral |
| Background | Pegylated Interferon (peg-IFN) | Unknown | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 600 mg | Oral |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |