Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:October 2011
End Date:February 2017
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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An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior
BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition
of these drugs can result in higher cure rates in patients who previously failed therapy.
Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received
placebo will be treated with active drugs in this study.

- Intervention Model:

- Parallel: for all subjects entering the trial

- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require
rescue therapy after initial treatment in this study

- Peginterferon Alfa-2a (pegIFNα-2a)

- Ribavirin (RBV)

- Daclatasvir (DCV)

- Asunaprevir (ASV)

Inclusion Criteria:

- Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to
control arm (Peginterferon α/Ribavirin + Placebo) during the trial

- HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)

- HCV RNA viral load detectable

Exclusion Criteria:

- Discontinuation from prior BMS HCV clinical trial due to a
Peginterferon/Ribavirin-related event

- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or
BMS-791325

- Positive for Hepatitis B infection (Hepatitis B surface antigen (HBsAg)) or Human
immunodeficiency virus 1 (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
20
sites
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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Philadelphia, PA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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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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Annandale, Virginia 22031
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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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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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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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Durham, NC
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Gainesville, Florida 32610
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Gainesville, FL
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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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La Jolla, CA
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Los Angeles, CA
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Madison, Wisconsin 53715
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Madison, WI
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Manhasset, NY
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Montgomery, AL
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Nashville, Tennessee 37205
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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San Antonio, Texas 78215
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Tulsa, Oklahoma 74137
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