Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2012
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00704405
Start Date
March 27 2009
End Date
September 10 2012
Last Update
October 9 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.