Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
NCT ID: NCT01492504
Last Updated: 2019-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1850 participants
OBSERVATIONAL
2012-02-07
2018-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with chronic hepatitis C
Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C
Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\]
Interventions
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Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\]
Eligibility Criteria
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Inclusion Criteria
* Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
* Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
* Completed the required post-treatment follow-up period in previous study
* Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
* Men and women, ages 18 and older
Exclusion Criteria
* Subject must not be participating in any other trial, excluding non-interventional trials
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Southern California Research Center
Coronado, California, United States
Scripps Clinic
La Jolla, California, United States
Keck Medical Center of USC, HCC 1
Los Angeles, California, United States
Peter J Ruane Md Inc
Los Angeles, California, United States
Anthony M. Mills Md Inc
Los Angeles, California, United States
Precision Research Institute, Llc
San Diego, California, United States
Quest Clinical Research
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
U.Cal.-San Francisco
San Francisco, California, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Schiff Center for Liver Diseases
Miami, Florida, United States
University Of Miami School Of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Florida Hospital Transplant Center
Orlando, Florida, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
University Of Michigan
Ann Arbor, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Southwest Care Center
Santa Fe, New Mexico, United States
Nyu Medical Center
Great Neck, New York, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
Mayo Clinic Rochester
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University Of Pennsylvania School Of Medicine
Philadelphia, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Liver Associates Of Texas
Houston, Texas, United States
MEDVAMC
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Metropolitan Research
Annandale, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States
Mcguire Dvamc
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Ssm Health Dean Med Group
Madison, Wisconsin, United States
Fundacion Cidea De Paraguay
Ciudad de Buenos Aires, Buenos Aires, Argentina
Centro Oncologico Integral
Mar del Plata, Buenos Aires, Argentina
Hospital Austral
Prov. Buenos Aires, Buenos Aires, Argentina
Instituto Centralizado De Asistencia E Investigacion Clinica
Prov de Santa Fe, Santa Fe Province, Argentina
Local Institution
Buenos Aires, , Argentina
Hospital Italiano De Buenos Aires
Buenos Aires, , Argentina
Local Institution
Camperdown, New South Wales, Australia
Local Institution
Darlinghurst, New South Wales, Australia
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Darlinghurst Nsw, New South Wales, Australia
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Randwick, New South Wales, Australia
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Westmead, New South Wales, Australia
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Woollongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Clayton Vic, Victoria, Australia
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Melbourne, Victoria, Australia
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Porto Alegre, Rio Grande do Sul, Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
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Regina, Saskatchewan, Canada
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Hvidovre, , Denmark
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Odense, , Denmark
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Clichy, , France
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Créteil, , France
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La Roche-sur-Yon, , France
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Lille, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Düsseldorf, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Mainz, , Germany
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland
St. James'S Hospital
Dublin, Dublin, Ireland
Local Institution
Brescia, , Italy
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Cisanello (pisa), , Italy
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Milan, , Italy
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Pavia, , Italy
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Torino, , Italy
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Viale Del Policlinico, 155, , Italy
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Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Ogaki-shi, Gifu, Japan
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Hiroshima, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Amagasaki-shi, Hyōgo, Japan
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Kanazawa, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Sendai, Miyagi, Japan
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Okayama, Okayama-ken, Japan
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Osaka, Osaka, Japan
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Osaka-sayama-shi, Osaka, Japan
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Suita, Osaka, Japan
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Suita-shi, Osaka, Japan
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Iruma-gun, Saitama, Japan
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Bunkyo-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Musashino-shi, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Chuo-shi, Yamanashi, Japan
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Bialystok, , Poland
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San Juan, , Puerto Rico
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Yangsan, Gyeongsangnam-do, South Korea
Local Institution
Busan, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Santiago de Compostela, , Spain
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Seville, , Spain
Local Institution
Valencia, , Spain
Local Institution
Gothenburg, , Sweden
Local Institution
Stockholm, , Sweden
Local Institution
Taichung, , Taiwan
Kings College Hospital
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Imperial College London
London, Greater London, United Kingdom
North Manchester General Hospital
Manchester, Greater Manchester, United Kingdom
Gartnaval General Hospital
Glasgow, , United Kingdom
Countries
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References
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Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.
Related Links
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Investigator Inquiry Form
Other Identifiers
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2011-005287-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-046
Identifier Type: -
Identifier Source: org_study_id
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