UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis



Status:Completed
Conditions:Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, 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 Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without
Ribavirin in treatment naive cirrhotic subjects.

Masking is Double blind for RBV: two or more parties are unaware of the intervention
assignment.

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

Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1

- Subjects with compensated cirrhosis

- HCV RNA ≥ 10,000 IU/mL at screening

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

- Treatment-experienced subjects are eligible including exposure to anti-HCV agents of
a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir
(ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include,
but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B
(NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Exclusion Criteria:

- Subjects without cirrhosis

- Liver or any other organ transplant

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

- Documented or suspected hepatocellular carcinoma(HCC)

- Evidence of decompensated liver disease including, but not limited to, radiologic
criteria, a history or presence of ascites, bleeding varices, or hepatic
encephalopathy
We found this trial at
27
sites
Houston, Texas 77030
572
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Houston, TX
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
609
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Chicago, IL
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
1116
mi
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Falls Church, VA
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
1062
mi
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Jacksonville, FL
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
1320
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South Miami, FL
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Alexandria, Virginia 22306
1124
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Alexandria, VA
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Allentown, Pennsylvania 18105
1210
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Allentown, PA
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Asheville, North Carolina 28801
857
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Asheville, NC
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402
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Aurora, CO
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Binghamton, New York 13903
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Binghamton, NY
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898
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Cleveland, OH
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Darlinghurst, New South Wales
8648
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Darlinghurst,
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
mi
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Durham, NC
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Indianapolis, Indiana 46202
643
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Indianapolis, IN
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Kansas City, Missouri 64111
196
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Kansas City, MO
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425 Volker Boulevard
Kansas City, Missouri 64131
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Kansas City, MO
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
1145
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La Jolla, CA
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Madison, Wisconsin 53715
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Madison, WI
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Marietta, Georgia 30060
788
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Nashville, Tennessee 37211
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New York, New York 10021
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Norfolk, Virginia 23502
1186
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Norfolk, VA
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
1142
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Orlando, FL
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San Antonio, Texas 78215
575
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San Diego, California 92123
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San Diego, CA
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San Francisco, California 94115
1340
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Statesville, North Carolina 28677
945
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Statesville, NC
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