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)

• Status: Completed
• Trial end date: 2012-09-10
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferons; Ribavirin

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