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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

26. november 2019 oppdatert av: Bristol-Myers Squibb

A Long-Term Follow-up Study of 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

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Forventet)

1850

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1119
        • Local Institution
      • Buenos Aires, Argentina, C1181
        • Hospital Italiano de Buenos Aires
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Fundacion Cidea De Paraguay
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Centro Oncologico Integral
      • Prov. Buenos Aires, Buenos Aires, Argentina, 1629
        • Hospital Austral
    • Santa FE
      • Prov De Santa Fe, Santa FE, Argentina, 2000
        • Instituto Centralizado De Asistencia E Investigacion Clinica
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Darlinghurst Nsw, New South Wales, Australia, 2010
        • Local Institution
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Woollongabba, Queensland, Australia, 4102
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australia, 3168
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
  • Brasil
      • Rio De Janeiro, Brasil, 20270-004
        • Local Institution
      • Rio De Janeiro, Brasil, 21040-000
        • Local Institution
      • Sao Paulo, Brasil, 04035-970
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brasil, 90035-003
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Local Institution
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3M9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Local Institution
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Local Institution
  • Danmark
      • Hvidovre, Danmark, 2650
        • Local Institution
      • Odense, Danmark, 5000
        • Local Institution
  • Forente stater
    • Alabama
      • Montgomery, Alabama, Forente stater, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • Beverly Hills, California, Forente stater, 90211-2145
        • Pacific Oaks Medical Group
      • Coronado, California, Forente stater, 92118
        • Southern California Research Center
      • La Jolla, California, Forente stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forente stater, 90033
        • Keck Medical Center of USC, HCC 1
      • Los Angeles, California, Forente stater, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, Forente stater, 90069
        • Anthony M. Mills Md Inc
      • San Diego, California, Forente stater, 92123
        • Medical Associates Research Group
      • San Diego, California, Forente stater, 92114
        • Precision Research Institute, LLC
      • San Diego, California, Forente stater, 92120
        • Quest Clinical Research
      • San Francisco, California, Forente stater, 94143
        • U.Cal.-San Francisco
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University Of Colorado Denver & Hospital
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520-8019
        • Yale New Haven Hospital
    • Florida
      • Miami, Florida, Forente stater, 33136
        • University of Miami School of Medicine
      • Miami, Florida, Forente stater, 33136
        • Schiff Center for Liver Diseases
      • Orlando, Florida, Forente stater, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Forente stater, 32804
        • Florida Hospital Transplant Center
    • Georgia
      • Marietta, Georgia, Forente stater, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Ruth M. Rothstein CORE Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, Forente stater, 21202
        • Mercy Medical Center
      • Catonsville, Maryland, Forente stater, 21228
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins University
    • Massachusetts
      • Springfield, Massachusetts, Forente stater, 01105
        • The Research Institute
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63104
        • Saint Louis University
    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
        • Southwest CARE Center
    • New York
      • Great Neck, New York, Forente stater, 11021
        • NYU Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7584
        • University Of North Carolina At Chapel Hill School Of Med
      • Charlotte, North Carolina, Forente stater, 28204
        • Carolinas Medical Center
      • Statesville, North Carolina, Forente stater, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74135
        • Healthcare Research Consultants
      • Tulsa, Oklahoma, Forente stater, 74104
        • Mayo Clinic Rochester
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18102
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania School of Medicine
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • Gastro One
      • Nashville, Tennessee, Forente stater, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Forente stater, 76012
        • Texas Clinical Research Institute
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forente stater, 77030
        • Liver Associates of Texas
      • Houston, Texas, Forente stater, 77030
        • MEDVAMC
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Lifetree Clinical Research
    • Virginia
      • Annandale, Virginia, Forente stater, 22003
        • Metropolitan Research
      • Falls Church, Virginia, Forente stater, 22042
        • INOVA Fairfax Hospital
      • Richmond, Virginia, Forente stater, 23249
        • McGuire DVAMC
      • Richmond, Virginia, Forente stater, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53715
        • Ssm Health Dean Med Group
  • Frankrike
      • Clichy Cedex, Frankrike, 92118
        • Local Institution
      • Creteil Cedex, Frankrike, 94010
        • Local Institution
      • La Roche-sur-yon Cedex 9, Frankrike, 85925
        • Local Institution
      • Lille, Frankrike, 59037
        • Local Institution
      • Limoges, Frankrike, 87042
        • Local Institution
      • Lyon Cedex 04, Frankrike, 69317
        • Local Institution
      • Marseille Cedex 08, Frankrike, 13285
        • Local Institution
      • Montpellier Cedex 5, Frankrike, 34295
        • Local Institution
      • Nice Cedex 03, Frankrike, 06202
        • Local Institution
      • PESSAC Cedex, Frankrike, 33604
        • Local Institution
      • Paris Cedex 12, Frankrike, 75571
        • Local Institution
      • Paris Cedex 13, Frankrike, 75651
        • Local Institution
      • Paris Cedex 14, Frankrike, 75679
        • Local Institution
      • Toulouse Cedex 09, Frankrike, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, Frankrike, 54511
        • Local Institution
  • Irland
    • Dublin
      • Dublin 3, Dublin, Irland
        • Mater Misericordiae University Hospital
      • Dublin 8, Dublin, Irland
        • St. James's Hospital
  • Italia
      • Brescia, Italia, 25123
        • Local Institution
      • Cisanello (pisa), Italia, 56124
        • Local Institution
      • Milano, Italia, 20127
        • Local Institution
      • Pavia, Italia, 27100
        • Local Institution
      • Torino, Italia, 10126
        • Local Institution
      • Viale Del Policlinico, 155, Italia, 00161
        • Local Institution
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4668560
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kurume, Fukuoka, Japan, 8300011
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 7340037
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0600033
        • Local Institution
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 6608511
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 7608557
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
      • Suita, Osaka, Japan, 5640013
        • Local Institution
      • Suita-shi, Osaka, Japan, 5650871
        • Local Institution
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Local Institution
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 4093898
        • Local Institution
  • Korea, Republikken
      • Busan, Korea, Republikken, 49241
        • Local Institution
      • Busan, Korea, Republikken, 47392
        • Local Institution
      • Busan, Korea, Republikken, 602-715
        • Local Institution
    • Gyeongsangnam-do
      • Yangsan-si, Gyeongsangnam-do, Korea, Republikken, 50612
        • Local Institution
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62260
        • Local Institution
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64710
        • Local Institution
  • Polen
      • Bialystok, Polen, 15-540
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • Spania
      • Alicante, Spania, 03010
        • Local Institution
      • Barcelona, Spania, 08035
        • Local Institution
      • Barcelona, Spania, 08916
        • Local Institution
      • Madrid, Spania, 28007
        • Local Institution
      • Madrid, Spania, 28046
        • Local Institution
      • Madrid, Spania, 28222
        • Local Institution
      • Madrid, Spania, 28922
        • Local Institution
      • Malaga, Spania, 29071
        • Local Institution
      • Santiago De Compostela, Spania, 15706
        • Local Institution
      • Sevilla, Spania, 41014
        • Local Institution
      • Valencia, Spania, 46010
        • Local Institution
  • Storbritannia
      • Glasgow, Storbritannia, G12 0YN
        • Gartnaval General Hospital
    • Greater London
      • London, Greater London, Storbritannia, SE5 9RS
        • Kings College Hospital
      • London, Greater London, Storbritannia, SW17 0QT
        • Local Institution
      • London, Greater London, Storbritannia, W2 1NY
        • Imperial College London
    • Greater Manchester
      • Manchester, Greater Manchester, Storbritannia, M8 6RL
        • North Manchester General Hospital
  • Sverige
      • Gothenburg, Sverige, SE-416 85
        • Local Institution
      • Stockholm, Sverige, 141 86
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, 40447
        • Local Institution
  • Tyskland
      • Dusseldorf, Tyskland, 40237
        • Local Institution
      • Essen, Tyskland, 45122
        • Local Institution
      • Frankfurt, Tyskland, 60590
        • Local Institution
      • Hamburg, Tyskland, 20099
        • Local Institution
      • Hannover, Tyskland, 30625
        • Local Institution
      • Heidelberg, Tyskland, 69120
        • Local Institution
      • Mainz, Tyskland, 55101
        • Local Institution

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria

  • Signed Written Informed Consent
  • 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 have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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
Legemiddel: 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)]

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Durability of Sustained viral response [SVR] (time to loss of virologic response)
Tidsramme: 24 or 48-week Intervals
The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)
24 or 48-week Intervals

Sekundære resultatmål

Resultatmål
Tidsramme
Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12
Tidsramme: 24 or 48-week intervals
24 or 48-week intervals
Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality
Tidsramme: 24 or 48-week intervals
24 or 48-week intervals

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. februar 2012

Primær fullføring (Faktiske)

16. mars 2018

Studiet fullført (Faktiske)

19. mars 2018

Datoer for studieregistrering

Først innsendt

30. november 2011

Først innsendt som oppfylte QC-kriteriene

13. desember 2011

Først lagt ut (Anslag)

15. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AI444-046
  • 2011-005287-21 (EudraCT-nummer)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere