CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 443 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/NCT02332707
NCT02332707Phase 2Completed
CompareCT.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 GT1 and GT2 Infection

Merck Sharp & Dohme LLC·interventional·Posted Jan 7, 2015·Updated Jul 23, 2019

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, Uprifosbuvir, and 4 other interventions for Hepatitis C. Completed, enrolled 443 participants.

Detailed Summary

This is a randomized, three-part, open-label trial of grazoprevir (GZR; MK-5172) (100 mg) and uprifosbuvir (UPR; MK-3682) (300 mg or 450 mg), with either elbasvir (EBR; MK-8742) (50 mg) or ruzasvir (RZR; MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naïve (TN) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 UPR+GZR+RZR 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 UPR+GZR+RZR 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 7, 2015
Enrollment StartJan 22, 2015
Primary CompletionSep 16, 2016
Study CompletionDec 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.5 years ago

Interventions

Grazoprevirdrug

One GZR 100 mg tablet (Part A), or 2 FDC tablets containing GZR 50 mg per tablet (Part B), taken q.d.by mouth.

Uprifosbuvirdrug

Two or 3 UPR 150 mg (300 mg and 450 mg total daily dose) tablets (Part A), or 2 FDC tablets containing UPR 225 mg (Part B), taken q.d. by mouth.

Elbasvirdrug

One EBR 50 mg tablet (Part A), taken q.d. by mouth.

Ruzasvirdrug

Six RZR 10 mg (60 mg total daily dose) capsules (Part A), or 2 FDC tablets containing RZR 30 mg per tablet (Part B), taken q.d. by mouth.

Uprifosbuvir (+) Grazoprevir (+) Ruzasvirdrug

Two FDC tablets, each containing GZR 50 mg + UPR 225 mg + RZR 30 mg (Part B), taken q.d. by mouth.

Ribavirindrug

RBV 200 mg capsules taken b.i.d. at a total daily dose of 800-1400 mg based on participant body weight.