Study Comparing BMS-790052 (Daclatasvir) to Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2012
End Date:June 2014
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C


The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and
Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b
patients


Allocation: Randomized Stratified

Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1a or 1b

- HCV RNA viral load ≥ 10,000 IU/mL

- No prior treatment including but not limited to interferon, ribavirin and
direct-acting antivirals

- if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1
year

- Body Mass Index (BMI) of 18 to 35 kg/m2

- Negative for Human immunodeficiency virus (HIV) and Hepatitis B

Exclusion Criteria:

- Evidence of decompensated liver disease

- Evidence of medical condition contributing to chronic liver disease other than HCV
We found this trial at
23
sites
Statesville, North Carolina 28625
307
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Statesville, NC
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
493
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Birmingham, AL
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Annapolis, Maryland 21401
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Annapolis, MD
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Atlanta, Georgia 30342
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Aurora, Illinois 60504
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Aurora, IL
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Boston, Massachusetts 02111
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Boston, MA
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Bridgeport, Connecticut 06610
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Bridgeport, CT
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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...
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, TX
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Inglewood, California 90301
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Marietta, Georgia 30060
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Marietta, GA
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New York, New York 10016
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New York, NY
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
480
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New York, NY
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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...
793
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Orlando, FL
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Philadelphia, PA
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Phoenix, Arizona 85016
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Plymouth, Minnesota 55446
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Providence, Rhode Island 02903
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Providence, Rhode Island 02905
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San Diego, California 92123
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St Louis, Missouri 63110
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St Louis, MO
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933
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Wellington, FL
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