Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment



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

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a
and ribavirin can result in higher cure rates in patients who previously failed therapy and
may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.


Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1

- Non-responder to prior therapy with peginterferon alfa and ribavirin

- HCV RNA viral load of 100,00 IU/mL

- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic
HCV infection; for compensated cirrhotics can be any time prior to randomization
(compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study
population)

- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not
demonstrate hepatocellular carcinoma

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

Exclusion Criteria:

- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening

- Evidence of 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
36
sites
Saint Louis University
221 N Grand Blvd
St. Louis, Missouri 63103
(800) 758-3678
Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Indiana University
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...
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Indianapolis, IN
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Univ of Rochester Medical Center
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Miami Research Associates
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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Samuel S Stratton VAMC
Albany, New York 12208
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The North Texas Research Institute
Arlington, Texas 76012
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Arlington, TX
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Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado 80045
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Aurora, CO
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Digestive Disease Associates, PA
Baltimore, Maryland 21229
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Baltimore, MD
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Mercy Medical Center
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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James J. Peters VAMC
Bronx, New York 10468
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Bronx, NY
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Local Institution
Ciudad De Buenos Aires, Buenos Aires
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Metropolitan Research
Fairfax, Virginia 22031
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Fairfax, VA
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University Of Florida Hepatology
Gainesville, Florida 32610
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Gainesville, FL
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James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York 11201
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Great Neck, NY
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Liver Associates of Texas
Houston, Texas 77030
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Houston, TX
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St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas 77030
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Houston, TX
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Scripps Clinic
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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Johns Hopkins Medical Institutions
Lutherville, Maryland 21093
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Dean Clinic
Madison, Wisconsin 53715
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Madison, WI
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Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama 36116
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Montgomery, AL
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Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York 12701
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Monticello, NY
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Nashville Medical Research Institute
Nashville, Tennessee 37205
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Nashville, TN
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Ochsner Clinic Foundation
New Orleans, Louisiana 70121
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New Orleans, LA
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Univ of Pennsylvania
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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University Gastroenterology
Providence, Rhode Island 02905
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Providence, RI
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Alamo Medical Research
San Antonio, Texas 78215
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Desta Digestive Disease Medical Center
San Diego, California 92114
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University of California at San Francisco
San Francisco, California 94143
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California Pacific Medical Center
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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Kaiser Permanente Medical Center
San Francisco, California 94115
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The Research Institute
Springfield, Massachusetts 01107
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Springfield, MA
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Carolinas Center For Liver Disease
Statesville, North Carolina 28677
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Statesville, NC
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Healthcare Research Consultants
Tulsa, Oklahoma 74135
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Tulsa, OK
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