CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 573 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/NCT01717326
NCT01717326Phase 2Completed
CompareCT.gov

A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection

Merck Sharp & Dohme LLC·interventional·Posted Oct 30, 2012·Updated Feb 5, 2021

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, Elbasvir, and 2 other interventions for Hepatitis C. Completed, enrolled 573 participants.

Detailed Summary

This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2012
Enrollment StartFeb 7, 2013
Primary CompletionFeb 23, 2015
Study CompletionMay 6, 2015
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 13.7 years ago

Interventions

Grazoprevirdrug

100 mg tablet orally QD

Elbasvirdrug

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Placebo to Elbasvirdrug

Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)

Ribavirindrug

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight