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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

Phase 2

Withdrawn

• Conditions: Chronic Genotype 1 Hepatitis C Virus Infection
• Interventions: Drug: vaniprevir (MK7009)

• Registration Number: NCT00895882
• Lead Sponsor: Merck Sharp & Dohme LLC

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 1 hepatitis C virus (HCV)-infected patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Study Start: 2010-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vaniprevir (MK7009)	vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks
2	vaniprevir (MK7009)	vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4	24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data	72 Weeks

Secondary Outcome Measures

Name	Time	Method
1) Proportion of patients achieving SVR24 in Treatment Regimen 5	1) 24 weeks after end of study therapy