BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
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
1 other identifier
interventional
448
2 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2011
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedOctober 12, 2015
September 1, 2015
2 years
July 6, 2011
August 17, 2015
September 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Post-treatment Week 12
Secondary Outcomes (4)
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Post-treatment Week 12
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])
Study Arms (1)
Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
EXPERIMENTALInterventions
Tablet, Oral, 60 mg, once daily, 24 weeks
Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
Eligibility Criteria
You may qualify if:
- Participants chronically infected with Hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10,000 IU/mL at screening
- No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
- Self-described as Black-African American, Latino or White-Caucasian
- Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.
- Compensated cirrhotics were capped at approximately 25%
You may not qualify if:
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116, United States
Va Long Beach Healthcare System - 11
Long Beach, California, 90822, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University Of California, Davis Medical Center
Sacramento, California, 95817, United States
Ucsd Antiviral Research Center (Avrc)
San Diego, California, 92103, United States
Precision Research Institute, Llc
San Diego, California, 92115, United States
Medical Associates Research Group, Inc
San Diego, California, 92123, United States
Miami V.A. Healthcare System
Maimi, Florida, 33125, United States
University Of Miami
Miami, Florida, 33136, United States
Florida Hospital Transplant Center
Orlando, Florida, 32804, United States
Infectious Disease Research Institute, Inc
Tampa, Florida, 33614, United States
South Florida Center Of Gastroenterology, P.A.
Wellington, Florida, 33414, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401, United States
Atlanta Medical Center
Atlanta, Georgia, 30312, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Digestive Health Center
Ocean Springs, Mississippi, 39564, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Liver Associates Of Texas
Houston, Texas, 77030, United States
Research Specialists Of Texas
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Metropolitan Research
Annandale, Virginia, 22003, United States
Mcguire D V A M C
Richmond, Virginia, 23249, United States
Local Institution
San Juan, 00927, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BristolMyers Squibb Study Director
- Organization
- BristolMyers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
January 1, 2014
Last Updated
October 12, 2015
Results First Posted
September 16, 2015
Record last verified: 2015-09