Phase 2
Completed N=90
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
Source: ClinicalTrials.gov NCT00880763 ↗Enrolled (actual)
90
Serious AEs
6.7%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants Achieving Rapid Viral Response — 86.4; 95.0; 76.2; 20.0 Percentage of participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Rapid Viral Response |
86.4; 95.0; 76.2; 20.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4 |
100; 100; 100; 95 | — |
| SECONDARY Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4 |
100; 100; 100; 85 | — |
| SECONDARY Change From Baseline in HCV RNA in log10 at Week 4 |
6.6; 6.6; 6.6; 6.6; -6.5; -6.6 | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Event |
23; 22; 23; 22 | — |
| SECONDARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has chronic genotype 1 Hepatitis C infection
Exclusion Criteria
- Has not tolerated previous course of peg-IFN and ribavirin
- Has HIV
- Has Hepatitis B
- Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin
Data sourced from ClinicalTrials.gov (NCT00880763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.