At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 413 enrolled

Drug / intervention

Grazoprevir +5 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/NCT02332720

NCT02332720Phase 2Completed

Compare CT.gov

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT3, GT4, GT5, and GT6 Infection

Merck Sharp & Dohme LLC·interventional·Posted Jan 7, 2015·Updated Jul 30, 2019

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, Uprifosbuvir, and 4 other interventions for Hepatitis C. Completed, enrolled 413 participants.

Detailed Summary

This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172) (100 mg) and uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg) or ruzasvir (MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naive (TN) or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedJan 2015

Enrollment StartJan 2015

Primary CompletionSep 2016

Study CompletionMay 2017

TodayJul 2026

First PostedJan 7, 2015

Enrollment StartJan 28, 2015

Primary CompletionSep 19, 2016

Study CompletionMay 3, 2017

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 11.5 years ago

Interventions

Grazoprevirdrug

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Uprifosbuvirdrug

Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth.

Elbasvirdrug

Part A: one elbasvir 50 mg tablet taken q.d. by mouth.

Ruzasvirdrug

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

MK-3682Bdrug

Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Ribavirin (RBV)drug

Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.