NCT01710501

A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.

Conditions

• Chronic Hepatitis C (CHC)

Interventions

Type	Name	Description
DRUG	Grazoprevir	Grazoprevir tablet, orally, once per day at assigned dose
BIOLOGICAL	pegylated interferon alfa-2b	1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection
DRUG	Ribavirin	Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight
DRUG	Placebo	Placebo to match grazoprevir tablets to maintain dose blinding

Timeline

• Start date: 2012-12-07
• Primary completion: 2013-11-25
• Completion: 2014-01-29
• First posted: 2012-10-19
• Last updated: 2021-02-04
• Results posted: 2016-03-04