CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 238 enrolled
Drug / intervention
Boceprevir +3 moredrug
Likely dose
Boceprevir 800 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/NCT01425203
NCT01425203Phase 3Completed
CompareCT.gov

Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin

Merck Sharp & Dohme LLC·interventional·Posted Aug 29, 2011·Updated Feb 8, 2021

In Brief

A Phase 3 clinical trial evaluating Boceprevir, Placebo, and 2 other interventions for Chronic Hepatitis C Genotype 1. Completed, enrolled 238 participants.

Detailed Summary

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Genotype 1
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2011
Enrollment StartNov 23, 2011
Primary CompletionOct 21, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.8 years ago

Interventions

Boceprevirdrug

boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)

Placebodrug

boceprevir-matched placebo four 200-mg capsules PO TID.

peginterferon alfa-2bbiological

peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)

Ribavirindrug

ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).