drugset / Trial / NCT02204475

Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)

NCT02204475

Phase 3 Withdrawn Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid \[RNA\]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.

Timeline

Start
2014-11
Primary completion
2016-06
Completion
2016-09

Drugs

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