Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:July 2010
End Date:August 2012

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A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated
interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
virologic response rates at least 35% greater than those with placebo.


Inclusion Criteria:

- Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4

- HCV RNA viral load of ≥100,000 IU/mL

- No previous exposure to interferon, pegIFNα, or RBV

- Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months
prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1
infection are eligible, but will be capped at 10% of the randomized study population
(biopsy can be from any time period prior to randomization)

- Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12
months prior to randomization that do not demonstrate evidence of hepatocellular
carcinoma

- Body mass index of 18 to 35 kg/m^2

Exclusion Criteria:

- Positive for hepatitis B or HIV-1/HIV-2 antibody at screening

- Evidence of a medical condition associated with chronic liver disease other than HCV

- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
We found this trial at
34
sites
Gainesville, Florida 32610
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Gainesville, FL
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
642
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Indianapolis, IN
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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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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...
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South Miami, FL
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Arlington, Texas 76012
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Arlington, TX
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401
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Aurora, CO
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Baltimore, Maryland 21229
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Baltimore, MD
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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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Bronx, New York 10468
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Bronx, NY
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Chapel Hill, NC
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Darlinghurst, New South Wales
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Darlinghurst,
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Fairfax, Virginia 22031
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Fairfax, VA
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Great Neck, New York 11201
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Great Neck, NY
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569
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Houston, TX
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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...
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Cli
Los Angeles, California 90048
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1101 East 33rd Street
Lutherville, Maryland 21093
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Lutherville, MD
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Madison, Wisconsin 53715
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Madison, WI
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754
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Montgomery, AL
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Monticello, NY
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Nashville, Tennessee 37205
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Nashville, TN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70121
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Providence, Rhode Island 02905
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San Antonio, Texas 78215
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San Diego, California 92114
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94115
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Springfield, Massachusetts 01105
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Statesville, North Carolina 28677
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Tulsa, Oklahoma 74137
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Tulsa, Oklahoma 74135
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