drugset / Trial / 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)

NCT01710501

Phase 2 Completed 87 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-12-07
Primary completion
2013-11-25
Completion
2014-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject GRAZOPREVIR ANHYDROUS Small molecule 25 mg Oral
Subject GRAZOPREVIR ANHYDROUS Small molecule 50 mg Oral
Subject GRAZOPREVIR ANHYDROUS Small molecule 100 mg Oral
Background Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Background Ribavirin Small molecule 800 mg Oral
Background Ribavirin Small molecule 1400 mg Oral