CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
BMS-790052 +4 moredrug
Likely dose
BMS-790052 10 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/NCT01016912
NCT01016912Phase 2Completed

A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Bristol-Myers Squibb·interventional·Posted Nov 20, 2009·Updated Oct 12, 2015

In Brief

A Phase 2 clinical trial evaluating BMS-790052, Placebo, and 2 other interventions for Hepatitis C Infection. Completed, enrolled 51 participants across 6 sites.

Detailed Summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2009
Enrollment StartDec 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.6 years ago

Interventions

BMS-790052drug

Tablets, Oral, 10 mg, daily, 24-48 weeks

BMS-790052drug

Tablets, Oral, 60 mg, daily, 24-48 weeks

Placebodrug

Tablets, Oral, 0 mg, daily, 48 weeks

Peginterferon alfa-2bdrug

Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks

Ribavirindrug

Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks