At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 237 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/NCT02092350

NCT02092350Phase 3Completed

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A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease

Merck Sharp & Dohme LLC·interventional·Posted Mar 20, 2014·Updated Sep 24, 2018

In Brief

A Phase 3 clinical trial evaluating Grazoprevir, Elbasvir, and 2 other interventions for Hepatitis C Virus. Completed, enrolled 237 participants.

Detailed Summary

This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C Virus

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartMar 2014

First PostedMar 2014

Primary CompletionMar 2015

Study CompletionSep 2015

TodayJul 2026

First PostedMar 20, 2014

Enrollment StartMar 17, 2014

Primary CompletionMar 11, 2015

Study CompletionSep 2, 2015

TodayJul 2, 2026

Enrollment to primary: 12 monthsPosted 12.3 years ago

Interventions

Grazoprevirdrug

Grazoprevir 100 mg tablet

Elbasvirdrug

Elbasvir 50 mg tablet

Placebo to Grazoprevirdrug

Placebo tablet matched to grazoprevir

Placebo to Elbasvirdrug

Placebo tablet matched to elbasvir