Phase 2
Completed N=211
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00704405 ↗
Enrolled (actual)
211
Serious AEs
8.1%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. — 71.1; 84.2; 78.0; 19.0 Percentage of participants — p=<0.001
Summary
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. |
71.1; 84.2; 78.0; 19.0 | <0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) |
38; 42; 40; 46; 41 | — |
| PRIMARY Number of Participants Discontinuing From Study Treatment Due to AEs |
2; 3; 2; 4; 1 | — |
| SECONDARY Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d. |
66.7; 19.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving cEVR |
92.0; 85.4; 9.5 | — |
| SECONDARY Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d. |
71.1; 36.6 | — |
Eligibility Criteria
Inclusion criteria
- Has chronic HCV genotype 1 infection
- Is treatment-experienced
- For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
Exclusion criteria
- Has not tolerated previous course peg-IFN and RBV
- Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
- Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
- Consumes excessive amounts of alcohol
- Has a history of drug or alcohol abuse
- If female, participant is pregnant or breastfeeding
- Has been in a clinical trail with an investigational drug in the last 30 days
- Has used IFN/Peg-IFN and RBV in the last 3 months
Data sourced from ClinicalTrials.gov (NCT00704405). 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.