UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2013
End Date:November 2014

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A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and
treatment experienced non-cirrhotic subjects


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1

- HCV RNA ≥ 10,000 IU/mL at screening

- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie,
IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)

- Treatment-experienced subjects are eligible

Exclusion Criteria:

- Evidence of cirrhosis

- Liver or any other organ transplant

- Current or known history of cancer within 5 years prior to enrollment

- Documented or suspected HCC

- Evidence of decompensated liver
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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6141 Sunset Dr # 301
South Miami, Florida 33143
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Alexandria, Virginia 22306
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Allentown, Pennsylvania 18105
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Asheville, North Carolina 28801
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Bronx, New York 10468
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Catonsville, Maryland 21228
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5841 S Maryland Ave
Chicago, Illinois 60637
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Darlinghurst, New South Wales
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2301 Erwin Rd
Durham, North Carolina 27710
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77030
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545 Barnhill Dr
Indianapolis, Indiana 46201
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Kansas City, Missouri 64111
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425 Volker Boulevard
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10666 N Torrey Pines Rd
La Jolla, California 92037
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Lutherville, Maryland 21093
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Madison, Wisconsin 53715
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Novi, Michigan 48377
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1701 North Mills Avenue
Orlando, Florida 32803
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243 N Rd
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Saint Louis, Missouri 63110
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Vineland, New Jersey 08360
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Wilmington, North Carolina 28403
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Winston-salem, North Carolina 27103
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