Phase 2
Completed N=95
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Source: ClinicalTrials.gov NCT00704184 ↗Enrolled (actual)
95
Serious AEs
9.6%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants Achieving RVR — 5.6; 75.0; 78.9; 68.8 Percentage of Participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving RVR |
5.6; 75.0; 78.9; 68.8; 83.3 | <0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) |
18; 15; 18; 16; 18 | — |
| PRIMARY Number of Participants Discontinuing From Study Therapy Due to AEs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With ≥2-log10 Decrease in HCV RNA |
16; 16; 19; 16; 17 | — |
| SECONDARY Number of Participants With ≥3-log10 Decrease in HCV RNA |
15; 16; 19; 16; 17 | — |
| SECONDARY Mean Log Change From Baseline in HCV RNA |
-3.6; -6.1; -6.3; -6.2; -6.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has chronic Genotype 1 Hepatitis C infection
Exclusion Criteria
- Subject has been previously treated for HCV
- Has Human Immunodeficiency Virus (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 (NCT00704184). 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.