CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 117 enrolled
Drug / intervention
EBR/GZR (50 mg/100 mg) FDCdrug
Likely dose
EBR/GZR (50 mg/100 mg) FDCfrom 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/NCT03111108
NCT03111108Phase 4Completed
CompareCT.gov

A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection

Merck Sharp & Dohme LLC·interventional·Posted Apr 12, 2017·Updated Jun 9, 2020

In Brief

A Phase 4 clinical trial evaluating EBR/GZR (50 mg/100 mg) FDC for Hepatitis C Virus (HCV) Infection. Completed, enrolled 117 participants across 13 sites.

Detailed Summary

The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV) Infection
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 12, 2017
Enrollment StartJun 20, 2017
Primary CompletionOct 15, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.2 years ago

Interventions

EBR/GZR (50 mg/100 mg) FDCdrug

One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.