CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 512 enrolled
Drug / intervention
BMS-790052 +4 moredrug
Likely dose
BMS-790052 20 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/NCT01170962
NCT01170962Phase 2Completed
CompareCT.gov

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

Bristol-Myers Squibb·interventional·Posted Jul 28, 2010·Updated Oct 12, 2015

In Brief

A Phase 2 clinical trial evaluating BMS-790052, Placebo, and 2 other interventions for Hepatitis C Virus. Completed, enrolled 512 participants across 72 sites in 11 countries.

Detailed Summary

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesArgentina, Australia, Canada, Denmark, France, Germany, Italy, Mexico, Puerto Rico, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2010
Enrollment StartAug 1, 2010
Primary CompletionJun 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.9 years ago

Interventions

BMS-790052drug

Film coated tablet, Oral, 20 mg, once daily, 24 weeks

BMS-790052drug

Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks

Placebodrug

Film coated tablet, Oral, 0mg, Once daily, 24 weeks

peginterferon alfa-2adrug

Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks

ribavirindrug

Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks