At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 143 enrolled
Drug / intervention
Grazoprevir/Elbasvir FDC +1 moredrug
Likely dose
Grazoprevir/Elbasvir FDC 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.
A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection
In Brief
A Phase 2 clinical trial evaluating Grazoprevir/Elbasvir FDC and Sofosbuvir for Hepatitis C. Completed, enrolled 143 participants.
Detailed Summary
This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJun 2014
Primary CompletionNov 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedMay 7, 2014
Enrollment StartJun 13, 2014
Primary CompletionNov 2, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.2 years ago
Interventions
Grazoprevir/Elbasvir FDCdrug
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Sofosbuvirdrug
Sofosbuvir 400mg tablet taken q.d. by mouth.