BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01389323
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
- 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%
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin Daclatasvir - Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin Peg-Interferon Alfa-2a - Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin Ribavirin -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) Post-treatment Week 12 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \<LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. 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.
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 The limit of detection for HCV RNA levels 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.
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]) An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Trial Locations
- Locations (36)
Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Triple O Research Institute, P.A.
🇺🇸West Palm Beach, Florida, United States
University Of Miami
🇺🇸Miami, Florida, United States
Ucsd Antiviral Research Center (Avrc)
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc
🇺🇸San Diego, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Carolinas Center For Liver Disease
🇺🇸Statesville, North Carolina, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Liver Associates Of Texas
🇺🇸Houston, Texas, United States
Research Specialists Of Texas
🇺🇸Houston, Texas, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Miami V.A. Healthcare System
🇺🇸Maimi, Florida, United States
Metropolitan Research
🇺🇸Annandale, Virginia, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Florida Hospital Transplant Center
🇺🇸Orlando, Florida, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
🇺🇸Baltimore, Maryland, United States
Local Institution
🇵🇷San Juan, Puerto Rico
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Va Long Beach Healthcare System - 11
🇺🇸Long Beach, California, United States
Alabama Liver & Digestive Specialists (Alds)
🇺🇸Montgomery, Alabama, United States
Precision Research Institute, Llc
🇺🇸San Diego, California, United States
South Florida Center Of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Mcguire D V A M C
🇺🇸Richmond, Virginia, United States
University Of North Carolina At Chapel Hill School Of Med
🇺🇸Chapel Hill, North Carolina, United States
Digestive Health Center
🇺🇸Ocean Springs, Mississippi, United States
University Of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Infectious Disease Research Institute, Inc
🇺🇸Tampa, Florida, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States