BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:January 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
36
sites
Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Carolinas Medical Center
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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University of Miami
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Metropolitan Research
Annandale, Virginia 22031
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Annandale, VA
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Texas Clinical Research Institute
Arlington, Texas 76012
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Arlington, TX
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The Emory Clinic
Atlanta, Georgia 30322
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Atlanta, GA
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Atlanta Medical Center
Atlanta, Georgia 30312
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Atlanta, GA
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Digestive Disease Associates, PA
Baltimore, Maryland 21229
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Baltimore, MD
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Mercy Medical Center
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, MD
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University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Research Specialists of Texas
Houston, Texas 77030
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Houston, TX
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Liver Associates of Texas
Houston, Texas 77030
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Houston, TX
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Va Long Beach Healthcare System - 11
Long Beach, California 90822
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Long Beach, CA
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Greater Los Angeles Healthcare System
Los Angeles, California 90073
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Los Angeles, CA
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Axis Clinical Trials
Los Angeles, California 90036
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Los Angeles, CA
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Miami V.A. Healthcare System
Maimi, Florida 33125
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Maimi, FL
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Loyola University Medical Center
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama 36116
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Montgomery, AL
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Tulane University Health Sciences Center
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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Digestive Health Center
Ocean Springs, Mississippi 39564
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Ocean Springs, MS
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Florida Hospital Transplant Center
Orlando, Florida 32804
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Orlando, FL
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Mcguire D V A M C
Richmond, Virginia 23249
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Richmond, VA
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University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Texas Liver Institute
San Antonio, Texas 78215
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San Antonio, TX
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Brooke Army Medical Center
San Antonio, Texas 78234
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San Antonio, TX
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Medical Associates Research Group
San Diego, California 92123
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San Diego, CA
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Ucsd Antiviral Research Center (Avrc)
San Diego, California 92103
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San Diego, CA
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Precision Research Institute, LLC
San Diego, California 92115
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Local Institution
San Juan, 00910
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San Juan,
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The Research Institute
Springfield, Massachusetts 01107
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Springfield, MA
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Carolinas Center For Liver Disease
Statesville, North Carolina 28677
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Statesville, NC
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Infectious Disease Research Institute, Inc.
Tampa, Florida 33614
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Tampa, FL
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South Florida Center of Gastroenterology, LLC
Wellington, Florida 33414
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Wellington, FL
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Triple O Research Institute, P.A.
West Palm Beach, Florida 33401
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West Palm Beach, FL
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