Clinical trial NCT01389323: BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
timeFrame: Post-treatment Week 12
Secondary outcomes:
measure: 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
timeFrame: Post-treatment Week 12
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24
measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
timeFrame: 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
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
timeFrame: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: Long Beach
country: United States
facility: Va Long Beach Healthcare System - 11
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Greater Los Angeles Healthcare System
state: California
city: Sacramento
country: United States
facility: University Of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: Ucsd Antiviral Research Center (Avrc)
state: California
city: San Diego
country: United States
facility: Precision Research Institute, Llc
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc
state: California
city: Maimi
country: United States
facility: Miami V.A. Healthcare System
state: Florida
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant Center
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute, Inc
state: Florida
city: Wellington
country: United States
facility: South Florida Center Of Gastroenterology, P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Ocean Springs
country: United States
facility: Digestive Health Center
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill School Of Med
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: Liver Associates Of Texas
state: Texas
city: Houston
country: United States
facility: Research Specialists Of Texas
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Richmond
country: United States
facility: Mcguire D V A M C
state: Virginia
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: