NCT01440595

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Grazoprevir	Grazoprevir 100 mg tablets once daily for 12 weeks.
DRUG	Placebo to Grazoprevir	Placebo to Grazoprevir once daily for 12 weeks
DRUG	Peginterferon alfa-2b (Peg-IFN)	Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
DRUG	Ribavirin (RBV)	Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Timeline

• Start date: 2011-11-28
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-09-26
• Last updated: 2024-05-22
• Results posted: 2016-03-04