Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014
End Date:December 2014

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A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C
virus (HCV) Genotype 3 infection


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Key Inclusion Criteria:

- Subjects must be able to understand and agree to comply with the prescribed dosing
regimens and procedures, report for regularly scheduled study visits, and reliably
communicate with study personnel about adverse events and concomitant medications

- Subjects chronically infected with hepatitis C virus (HCV) genotype 3

- Subjects who are HCV treatment-naive

- Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A
inhibitors is prohibited)

- HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

- HCV Genotypes other than genotype-3 infection; mixed genotype infections are not
permitted

- Liver or any other organ transplant (including hematopoietic stem cell transplants)
other than cornea and hair

- Current or known history of cancer (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to screening

- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained
imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this
was performed)

- 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
31
sites
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
493
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Manhasset, NY
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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...
318
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Falls Church, VA
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
1973
mi
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Los Angeles, CA
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3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
1513
mi
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Salt Lake City, UT
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Arlington, Texas 76012
927
mi
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Arlington, TX
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Asheville, North Carolina 28801
302
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Asheville, NC
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Atlanta, Georgia 30342
427
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Atlanta, GA
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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...
344
mi
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Baltimore, MD
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Baltimore, Maryland 21229
340
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Baltimore, MD
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761
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DeLand, FL
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Downers Grove, Illinois 60515
289
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Downers Grove, IL
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Gainesville, Florida 32610
713
mi
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Gainesville, FL
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Germantown, Tennessee 38138
501
mi
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425 Volker Boulevard
Kansas City, Missouri 64131
619
mi
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Kansas City, MO
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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...
1953
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La Jolla, CA
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Los Angeles, California 90036
1977
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Los Angeles, CA
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Los Angeles, California 90069
1978
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Marietta, Georgia 30060
425
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1516
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Murray, UT
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Pasadena, California 91105
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Perkasie, Pennsylvania 18944
408
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Pittsburgh, Pennsylvania 15213
163
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
490
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San Antonio, Texas 78215
1136
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San Antonio, TX
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San Diego, California 92115
1951
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San Diego, CA
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San Diego, California 92123
1947
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San Francisco, California 94115
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1800
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San Juan,
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Santa Fe, New Mexico 87505
1284
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Santa Fe, NM
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
2007
mi
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Seattle, WA
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Winston-salem, North Carolina 27103
307
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Winston-salem, NC
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