CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 enrolled
Drug / intervention
Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tabletsdrug
Likely dose
Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tabletsfrom 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/NCT02105662
NCT02105662Phase 3Completed
CompareCT.gov

A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV

Merck Sharp & Dohme LLC·interventional·Posted Apr 7, 2014·Updated Feb 5, 2021

In Brief

A Phase 3 clinical trial evaluating Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets for Chronic Hepatitis C. Completed, enrolled 218 participants.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 7, 2014
Enrollment StartJun 3, 2014
Primary CompletionFeb 20, 2015
Study CompletionMay 22, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago

Interventions

Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tabletsdrug

MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)