CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Grazoprevir +3 moredrug
Likely dose
pegylated interferon alfa-2b 1.5 mcg/kgfrom 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/NCT01710501
NCT01710501Phase 2Completed
CompareCT.gov

A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection

Merck Sharp & Dohme LLC·interventional·Posted Oct 19, 2012·Updated Feb 4, 2021

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, pegylated interferon alfa-2b, and 2 other interventions for Chronic Hepatitis C (CHC). Completed, enrolled 87 participants.

Detailed Summary

This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C (CHC)
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2012
Enrollment StartDec 7, 2012
Primary CompletionNov 25, 2013
Study CompletionJan 29, 2014
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 13.7 years ago

Interventions

Grazoprevirdrug

Grazoprevir tablet, orally, once per day at assigned dose

pegylated interferon alfa-2bbiological

1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection

Ribavirindrug

Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight

Placebodrug

Placebo to match grazoprevir tablets to maintain dose blinding