Phase 2
Completed N=45
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00943761 ↗
Enrolled (actual)
45
Serious AEs
11.1%
Results posted
Sep 2014
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event — 21; 23 Participants
Summary
This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event |
21; 23 | — |
| PRIMARY Number of Participants Who Experienced a Serious Adverse Event |
4; 1 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an Adverse Event |
2; 1 | — |
| PRIMARY Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) |
66.7; 70.6 | — |
Eligibility Criteria
Inclusion criteria
- Participant has participated in a prior vaniprevir clinical trial
- Participant agrees to use acceptable birth control method during treatment
Exclusion criteria
- More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
- Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
- Participant received any investigational therapy for HCV after participating in the prior study
Data sourced from ClinicalTrials.gov (NCT00943761). 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.