CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
Grazoprevir +3 moredrug
Likely dose
Grazoprevir 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/NCT02601573
NCT02601573Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection

Merck Sharp & Dohme LLC·interventional·Posted Nov 10, 2015·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, Elbasvir, and 2 other interventions for Hepatitis C. Completed, enrolled 101 participants.

Detailed Summary

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartJan 5, 2016
Primary CompletionOct 18, 2016
Study CompletionJan 6, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.6 years ago

Interventions

Grazoprevirdrug

GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.

Elbasvirdrug

EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

Ribavirindrug

RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).

Sofosbuvirdrug

SOF 400 mg tablet taken q.d. by mouth in the morning with food.