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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1850

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Local Institution
      • Darlinghurst, New South Wales, Australien, 2010
        • Local Institution
      • Darlinghurst Nsw, New South Wales, Australien, 2010
        • Local Institution
      • Randwick, New South Wales, Australien, 2031
        • Local Institution
      • Westmead, New South Wales, Australien, 2145
        • Local Institution
    • Queensland
      • Woollongabba, Queensland, Australien, 4102
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australien, 3168
        • Local Institution
      • Melbourne, Victoria, Australien, 3004
        • Local Institution
  • Brasilien
      • Rio De Janeiro, Brasilien, 20270-004
        • Local Institution
      • Rio De Janeiro, Brasilien, 21040-000
        • Local Institution
      • Sao Paulo, Brasilien, 04035-970
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brasilien, 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
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G12 0YN
        • Gartnaval General Hospital
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SE5 9RS
        • Kings College Hospital
      • London, Greater London, Det Forenede Kongerige, SW17 0QT
        • Local Institution
      • London, Greater London, Det Forenede Kongerige, W2 1NY
        • Imperial College London
    • Greater Manchester
      • Manchester, Greater Manchester, Det Forenede Kongerige, M8 6RL
        • North Manchester General Hospital
  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • Beverly Hills, California, Forenede Stater, 90211-2145
        • Pacific Oaks Medical Group
      • Coronado, California, Forenede Stater, 92118
        • Southern California Research Center
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forenede Stater, 90033
        • Keck Medical Center of USC, HCC 1
      • Los Angeles, California, Forenede Stater, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, Forenede Stater, 90069
        • Anthony M. Mills Md Inc
      • San Diego, California, Forenede Stater, 92123
        • Medical Associates Research Group
      • San Diego, California, Forenede Stater, 92114
        • Precision Research Institute, LLC
      • San Diego, California, Forenede Stater, 92120
        • Quest Clinical Research
      • San Francisco, California, Forenede Stater, 94143
        • U.Cal.-San Francisco
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University Of Colorado Denver & Hospital
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520-8019
        • Yale New Haven Hospital
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami School Of Medicine
      • Miami, Florida, Forenede Stater, 33136
        • Schiff Center for Liver Diseases
      • Orlando, Florida, Forenede Stater, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital Transplant Center
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Ruth M. Rothstein CORE Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21202
        • Mercy Medical Center
      • Catonsville, Maryland, Forenede Stater, 21228
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Forenede Stater, 21093
        • Johns Hopkins University
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01105
        • The Research Institute
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Saint Louis University
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • Southwest CARE Center
    • New York
      • Great Neck, New York, Forenede Stater, 11021
        • NYU Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7584
        • University Of North Carolina At Chapel Hill School Of Med
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Carolinas Medical Center
      • Statesville, North Carolina, Forenede Stater, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Healthcare Research Consultants
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Mayo Clinic Rochester
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18102
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania School of Medicine
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Gastro One
      • Nashville, Tennessee, Forenede Stater, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Forenede Stater, 76012
        • Texas Clinical Research Institute
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • Liver Associates of Texas
      • Houston, Texas, Forenede Stater, 77030
        • MEDVAMC
      • San Antonio, Texas, Forenede Stater, 78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Lifetree Clinical Research
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • Metropolitan Research
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital
      • Richmond, Virginia, Forenede Stater, 23249
        • McGuire DVAMC
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53715
        • Ssm Health Dean Med Group
  • Frankrig
      • Clichy Cedex, Frankrig, 92118
        • Local Institution
      • Creteil Cedex, Frankrig, 94010
        • Local Institution
      • La Roche-sur-yon Cedex 9, Frankrig, 85925
        • Local Institution
      • Lille, Frankrig, 59037
        • Local Institution
      • Limoges, Frankrig, 87042
        • Local Institution
      • Lyon Cedex 04, Frankrig, 69317
        • Local Institution
      • Marseille Cedex 08, Frankrig, 13285
        • Local Institution
      • Montpellier Cedex 5, Frankrig, 34295
        • Local Institution
      • Nice Cedex 03, Frankrig, 06202
        • Local Institution
      • PESSAC Cedex, Frankrig, 33604
        • Local Institution
      • Paris Cedex 12, Frankrig, 75571
        • Local Institution
      • Paris Cedex 13, Frankrig, 75651
        • Local Institution
      • Paris Cedex 14, Frankrig, 75679
        • Local Institution
      • Toulouse Cedex 09, Frankrig, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • Local Institution
  • Irland
    • Dublin
      • Dublin 3, Dublin, Irland
        • Mater Misericordiae University Hospital
      • Dublin 8, Dublin, Irland
        • St. James's Hospital
  • Italien
      • Brescia, Italien, 25123
        • Local Institution
      • Cisanello (pisa), Italien, 56124
        • Local Institution
      • Milano, Italien, 20127
        • Local Institution
      • Pavia, Italien, 27100
        • Local Institution
      • Torino, Italien, 10126
        • Local Institution
      • Viale Del Policlinico, 155, Italien, 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
  • Spanien
      • Alicante, Spanien, 03010
        • Local Institution
      • Barcelona, Spanien, 08035
        • Local Institution
      • Barcelona, Spanien, 08916
        • Local Institution
      • Madrid, Spanien, 28007
        • Local Institution
      • Madrid, Spanien, 28046
        • Local Institution
      • Madrid, Spanien, 28222
        • Local Institution
      • Madrid, Spanien, 28922
        • Local Institution
      • Malaga, Spanien, 29071
        • Local Institution
      • Santiago De Compostela, Spanien, 15706
        • Local Institution
      • Sevilla, Spanien, 41014
        • Local Institution
      • Valencia, Spanien, 46010
        • Local Institution
  • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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
Medicin: 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)]

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. februar 2012

Primær færdiggørelse (Faktiske)

16. marts 2018

Studieafslutning (Faktiske)

19. marts 2018

Datoer for studieregistrering

Først indsendt

30. november 2011

Først indsendt, der opfyldte QC-kriterier

13. december 2011

Først opslået (Skøn)

15. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner