Study to Evaluate the Safety, Tolerability, and Efficacy of MK-5172 When Administered Concomitantly with Pegylated-Interferon and Ribavirin in Patients with Chronic Genotype 2 or 3 Hepatitis C Virus Infection.
- Conditions
- HCV GT2/3MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-003299-36-IT
- Lead Sponsor
- MERCK SHARP & DOHME CORP.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
1.Patient has previously documented CHC GT2 or GT3 infection. Patients with other or mixed (e.g. GT2 and GT3) genotypes are not eligible. 2.Patient has HCV RNA value =10,000 IU/mL at screening. 3.Patient has no known cirrhosis.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1.Patient is known to be HIV positive or co-infected with active hepatitis B virus (HBsAg positive). 2.Patient received prior approved or investigational treatment for hepatitis C; other than herbal remedies, except those with known hepatotoxicity. 3.Patient has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC. 4.Patient has pre-existing psychiatric condition 5.Patient has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Patients under evaluation for malignancy are not eligible. 6.Female patient is pregnant, lactating, expecting to conceive or donate eggs OR Male patient is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using two methods of birth control throughout treatment and after the completion of all treatment. 7.Exclusionary laboratory values (Refer to protocol for complete list)
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