A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infectio
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virusChronic Hepatitis C Infection
- Registration Number
- EUCTR2009-012000-10-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 530
1.Patient (Men and women 18 to 65 years of age) has chronic genotype 1 HCV infection
2.Patient has had a liver biopsy without evidence of cirrhosis.
3.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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patient had previous treatment with:
a.Three or more doses of IFN, peg-IFN, and/or RBV.
b.IFN, peg-IFN, and/or RBV and discontinued treatment due to intolerance to one or more of these therapies.
c.Other antiviral or investigational therapies or vaccines for HCV.
2.Female patient is pregnant or breastfeeding
3.Patient has evidence or history of chronic hepatitis not caused by HCV
4.Patient has HIV
5.Patient has active hepatitis B infection
6.Patient has non-genotype 1 HCV infection
7.Patient consumes excessive amounts of alcohol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method