At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 448 enrolled
Drug / intervention
Daclatasvir +2 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.
Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection
In Brief
A Phase 3 clinical trial evaluating Daclatasvir, Peg-Interferon Alfa-2a, and 1 other intervention for Hepatitis C. Completed, enrolled 448 participants across 36 sites in 2 countries.
Detailed Summary
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartSep 2011
Primary CompletionSep 2013
Study CompletionJan 2014
TodayJul 2026
First PostedJul 8, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.0 years ago
Interventions
Daclatasvirdrug
Tablet, Oral, 60 mg, once daily, 24 weeks
Peg-Interferon Alfa-2adrug
Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
Ribavirindrug
Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response