At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 159 enrolled

Drug / intervention

Grazoprevir + Elbasvir +1 moredrug

Likely dose

Grazoprevir + Elbasvir 100 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02252016

NCT02252016Phase 3Completed

Compare CT.gov

A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection

Merck Sharp & Dohme LLC·interventional·Posted Sep 29, 2014·Updated Oct 3, 2018

In Brief

A Phase 3 clinical trial evaluating Grazoprevir + Elbasvir and Placebo for Hepatitis C. Completed, enrolled 159 participants.

Detailed Summary

This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedSep 2014

Enrollment StartOct 2014

Primary CompletionDec 2015

Study CompletionJun 2016

TodayJul 2026

First PostedSep 29, 2014

Enrollment StartOct 22, 2014

Primary CompletionDec 7, 2015

Study CompletionJun 14, 2016

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 11.8 years ago

Interventions

Grazoprevir + Elbasvirdrug

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Placebodrug

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.