CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 420 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/NCT02105701
NCT02105701Phase 3Completed
CompareCT.gov

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection

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

In Brief

A Phase 3 clinical trial evaluating Grazoprevir + Elbasvir and Ribavirin for Hepatitis C Infection. Completed, enrolled 420 participants.

Detailed Summary

This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 7, 2014
Enrollment StartJun 5, 2014
Primary CompletionMar 24, 2015
Study CompletionJun 19, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.2 years ago

Interventions

Grazoprevir + Elbasvirdrug

FDC tablet containing grazoprevir 100 mg and elbasvir 50 mg.

Ribavirindrug

200 mg capsule