CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 257 enrolled
Drug / intervention
Boceprevir +2 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/NCT01945294
NCT01945294Phase 3Completed
CompareCT.gov

A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia

Merck Sharp & Dohme LLC·interventional·Posted Sep 18, 2013·Updated Jul 12, 2018

In Brief

A Phase 3 clinical trial evaluating Boceprevir, Peg-interferon alfa-2b, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 257 participants.

Detailed Summary

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartOct 10, 2013
Primary CompletionAug 5, 2015
Study CompletionNov 4, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

Boceprevirdrug

800 mg three times daily orally

Peg-interferon alfa-2bbiological

1.5 mcg/kg weekly subcutaneously

Ribavirindrug

800-1400 mg twice-daily divided orally based on body weight