CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
Boceprevirdrug
Likely dose
Boceprevir 800mgfrom 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/NCT01585584
NCT01585584Phase 3Completed
CompareCT.gov

Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin

University of Calgary·interventional·Posted Apr 26, 2012·Updated Sep 21, 2015

In Brief

A Phase 3 clinical trial evaluating Boceprevir for Hepatitis C. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesCanada
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.2 years ago

Interventions

Boceprevirdrug

All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).