CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 368 enrolled
Drug / intervention
Grazoprevir +5 moredrug
Likely dose
Boceprevir 200 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/NCT01353911
NCT01353911Phase 2Completed
CompareCT.gov

A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Merck Sharp & Dohme LLC·interventional·Posted May 16, 2011·Updated May 22, 2024

In Brief

A Phase 2 clinical trial evaluating Grazoprevir, Boceprevir, and 4 other interventions for Hepatitis C, Chronic. Completed, enrolled 368 participants.

Detailed Summary

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartJun 27, 2011
Primary CompletionJan 20, 2013
Study CompletionMar 10, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago

Interventions

Grazoprevirdrug

Orally once daily in AM. Blinded or open-label depending on treatment arm.

Boceprevirdrug

Four 200 mg capsules orally three times daily.

Placebo for Grazoprevirdrug

Orally once daily in AM.

Placebo for Boceprevirdrug

Four capsules orally three times daily.

Peg-interferon alfa-2bdrug

1.5 μg/kg/week subcutaneous injection.

Ribavirindrug

300 mg to 700 mg orally twice daily.