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

Use our guide to learn which trials are right for you!

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
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Alexandria, Virginia 22306
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Allentown, Pennsylvania 18105
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Binghamton, New York 13903
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Darlinghurst, New South Wales
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
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...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Madison, Wisconsin 53715
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Statesville, North Carolina 28677
?
mi
from
Statesville, NC
Click here to add this to my saved trials