CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 605 enrolled
Drug / intervention
Daclatasvir +3 moredrug
Likely dose
Daclatasvir 60 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/NCT01492426
NCT01492426Phase 3Completed

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Bristol-Myers Squibb·interventional·Posted Dec 15, 2011·Updated Jun 3, 2016

In Brief

A Phase 3 clinical trial evaluating Daclatasvir, Telaprevir, and 2 other interventions for Hepatitis C. Completed, enrolled 605 participants across 91 sites in 16 countries.

Detailed Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Poland, Russia, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.5 years ago

Interventions

Daclatasvirdrug

Film-coated tablet, oral, 60 mg, once daily, 24 weeks

Telaprevirdrug

Film-coated tablet, oral, 750 mg, 3 times daily

Peginterferon alfa-2adrug

Solution for injection, subcutaneous injection, 180 μg, weekly

Ribavirindrug

Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day