A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection

NCT00895882 Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	WITHDRAWN
Start date	2010-11
Completion	2013-01

Conditions

• Chronic Genotype 1 Hepatitis C Virus Infection

Interventions

• vaniprevir (MK7009)
• Comparator: vaniprevir (MK7009)
• Comparator: Pegylated Interferon (peg-IFN) alfa-2a
• Comparator: Ribavirin
• Comparator: Placebo to vaniprevir

Primary outcomes

• 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