CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 257 enrolled
Drug / intervention
Sofosbuvir +3 moredrug
Likely dose
Grazoprevir/Elbasvir (100 mg/50 mg) FDCfrom 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/NCT02358044
NCT02358044Phase 3Completed
CompareCT.gov

A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1, 4 or 6 Infection

Merck Sharp & Dohme LLC·interventional·Posted Feb 6, 2015·Updated Oct 3, 2018

In Brief

A Phase 3 clinical trial evaluating Sofosbuvir, PegIntron, and 2 other interventions for Hepatitis C. Completed, enrolled 257 participants.

Detailed Summary

This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) \[PR\] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[SVR12\]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 6, 2015
Enrollment StartFeb 27, 2015
Primary CompletionNov 26, 2015
Study CompletionFeb 16, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.4 years ago

Interventions

Sofosbuvirdrug

400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.

PegIntronbiological

PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.

Ribavirindrug

Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.

Grazoprevir/Elbasvir (100 mg/50 mg) FDCdrug

Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.