Status:
WITHDRAWN
Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Genotype 1 Hepatitis C Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype ...
Eligibility Criteria
Inclusion
- Patient has chronic genotype 1 HCV infection
- Patient has had a liver biopsy without evidence of cirrhosis
- Patient has had an eye exam prior to the start of study
- Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study
Exclusion
- Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
- Female patient is pregnant or breastfeeding
- Patient has chronic hepatitis not caused by HCV
- Patient has evidence of cirrhosis of the liver
- Patient has HIV
- Patient has active hepatitis B infection
- Patient has non-genotype 1 HCV infection
- Patient consumes excessive amounts of alcohol
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00895882
Start Date
November 1 2010
End Date
January 1 2013
Last Update
October 22 2015
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