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 Infection - Safety, Tolerability, and Efficacy of MK-7009 study

Phase 1

• Conditions: Chronic hepatitis C infection; MedDRA version: 9.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus

• Registration Number: EUCTR2009-012000-10-BE
• Lead Sponsor: Merck Sharp & Dohme (Europe) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-26
• Study Completion: 2010-09-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 530

Inclusion Criteria

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 patient who is of childbearing potential or male patient with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control throughout treatment, and after completing all treatment, in accordance with the local peg-IFN and RBV product labels.
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

Exclusion Criteria

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