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A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

6. september 2019 oppdatert av: Novartis Pharmaceuticals
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Studieoversikt

Status

Ikke lenger tilgjengelig

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

  • To provide everolimus maintenance therapy through this access program and
  • To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
  • To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Studietype

Utvidet tilgang

Utvidet tilgangstype

  • Befolkning av middels størrelse

Kontakter og plasseringer

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

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3052
        • Novartis Investigative Site
  • Belgia
      • Bruxelles, Belgia, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgia, 1070
        • Novartis Investigative Site
      • Leuven, Belgia, 3000
        • Novartis Investigative Site
  • Brasil
    • MG
      • Belo Horizonte, MG, Brasil, 30110-934
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brasil, 90020-090
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brasil, 04023-900
        • Novartis Investigative Site
      • São Paulo, SP, Brasil, 05403-000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y6
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5A5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Novartis Investigative Site
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Novartis Investigative Site
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 115446
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Novartis Investigative Site
      • Birmingham, Alabama, Forente stater, 35294-0006
        • Novartis Investigative Site
      • Mobile, Alabama, Forente stater, 36617
        • Novartis Investigative Site
    • California
      • Los Angeles, California, Forente stater, 90048
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90027
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90095
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90024
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90057
        • Novartis Investigative Site
      • San Diego, California, Forente stater, 92103-8745
        • Novartis Investigative Site
      • San Francisco, California, Forente stater, 94115
        • Novartis Investigative Site
      • Stanford, California, Forente stater, 94304
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Novartis Investigative Site
      • Denver, Colorado, Forente stater, 80218
        • Novartis Investigative Site
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
        • Novartis Investigative Site
    • Florida
      • Gainesville, Florida, Forente stater, 32610-0277
        • Novartis Investigative Site
      • Tampa, Florida, Forente stater, 33606
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Novartis Investigative Site
      • Atlanta, Georgia, Forente stater, 30309
        • Novartis Investigative Site
      • Augusta, Georgia, Forente stater, 30912-3140
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Novartis Investigative Site
      • Chicago, Illinois, Forente stater, 60637
        • Novartis Investigative Site
      • Maywood, Illinois, Forente stater, 60153
        • Novartis Investigative Site
    • Iowa
      • Des Moines, Iowa, Forente stater, 50309
        • Novartis Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0293
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Novartis Investigative Site
      • New Orleans, Louisiana, Forente stater, 70121
        • Novartis Investigative Site
      • Shreveport, Louisiana, Forente stater, 71103
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Novartis Investigative Site
      • Worcester, Massachusetts, Forente stater, 01655
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0331
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Novartis Investigative Site
      • Saint Louis, Missouri, Forente stater, 63104-1314
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • Novartis Investigative Site
    • New Jersey
      • Livingston, New Jersey, Forente stater, 07039
        • Novartis Investigative Site
      • New Brunswick, New Jersey, Forente stater, 08901
        • Novartis Investigative Site
    • New York
      • Albany, New York, Forente stater, 12208
        • Novartis Investigative Site
      • Bronx, New York, Forente stater, 10467
        • Novartis Investigative Site
      • Buffalo, New York, Forente stater, 14203
        • Novartis Investigative Site
      • New York, New York, Forente stater, 10032
        • Novartis Investigative Site
      • Valhalla, New York, Forente stater, 10595
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Novartis Investigative Site
      • Greenville, North Carolina, Forente stater, 27834
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Novartis Investigative Site
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Novartis Investigative Site
      • Cleveland, Ohio, Forente stater, 44106-5048
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43210
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43205-2696
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Forente stater, 19102 2293
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Novartis Investigative Site
      • Charleston, South Carolina, Forente stater, 29403
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37212
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Forente stater, 75246
        • Novartis Investigative Site
      • Galveston, Texas, Forente stater, 77555-0144
        • Novartis Investigative Site
      • Houston, Texas, Forente stater, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, Forente stater, 78229
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, Forente stater, 84157
        • Novartis Investigative Site
      • Salt Lake City, Utah, Forente stater, 84132
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • Novartis Investigative Site
      • Norfolk, Virginia, Forente stater, 23507
        • Novartis Investigative Site
      • Richmond, Virginia, Forente stater, 23284
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25301
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Novartis Investigative Site
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Novartis Investigative Site
  • Frankrike
      • Brest, Frankrike, 29200
        • Novartis Investigative Site
      • Créteil, Frankrike, 94010
        • Novartis Investigative Site
      • Grenoble CEDEX, Frankrike, 38000
        • Novartis Investigative Site
      • Le Plessis Robinson, Frankrike, 92350
        • Novartis Investigative Site
      • Lyon, Frankrike, 69437
        • Novartis Investigative Site
      • Monpellier, Frankrike, 34295
        • Novartis Investigative Site
      • Nantes, Frankrike, 44035
        • Novartis Investigative Site
      • Paris, Frankrike, 75010
        • Novartis Investigative Site
      • Paris, Frankrike, 75651
        • Novartis Investigative Site
      • Saint-Etienne, Frankrike, 42055
        • Novartis Investigative Site
      • Toulouse, Frankrike, 31054
        • Novartis Investigative Site
      • Tours, Frankrike, 37044
        • Novartis Investigative Site
      • Vandoeuvre-Les-Nancy, Frankrike, 54511
        • Novartis Investigative Site
      • Villejuif, Frankrike, 94800
        • Novartis Investigative Site
  • Italia
    • MI
      • Milano, MI, Italia, 20162
        • Novartis Investigative Site
      • Milano, MI, Italia, 20122
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italia, 35128
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italia, 06100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italia, 56124
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italia, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italia, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00168
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italia, 53100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italia, 07100
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italia, 36100
        • Novartis Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1001
        • Novartis Investigative Site
  • Norge
      • Oslo, Norge, 0424
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen, 02-006
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-6528
        • Novartis Investigative Site
  • Spania
      • Madrid, Spania, 28041
        • Novartis Investigative Site
      • Madrid, Spania, 28034
        • Novartis Investigative Site
      • Madrid, Spania, 28222
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spania, 14004
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spania, 08907
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spania, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spania, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spania, 46026
        • Novartis Investigative Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spania, 48903
        • Novartis Investigative Site
  • Storbritannia
      • London, Storbritannia, SE1 9RT
        • Novartis Investigative Site
      • London, Storbritannia, E1 1BB
        • Novartis Investigative Site
      • Manchester, Storbritannia, M23 9LT
        • Novartis Investigative Site
      • Salford, Storbritannia, M6 8HD
        • Novartis Investigative Site
  • Sveits
      • Bern, Sveits, 3010
        • Novartis Investigative Site
      • Zuerich, Sveits, 8091
        • Novartis Investigative Site
  • Sør-Afrika
      • Johannesburg, Sør-Afrika, 2198
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
    • Taiwan ROC
      • Taichung, Taiwan ROC, Taiwan, 40201
        • Novartis Investigative Site
      • Tainan, Taiwan ROC, Taiwan, 70403
        • Novartis Investigative Site
  • Tsjekkia
      • Brno, Tsjekkia, 656 91
        • Novartis Investigative Site
      • Hradec Kralove, Tsjekkia, 505 00
        • Novartis Investigative Site
      • Ostrava-Poruba, Tsjekkia, 708 52
        • Novartis Investigative Site
      • Prague 4, Tsjekkia, 140 21
        • Novartis Investigative Site
  • Tyskland
      • Essen, Tyskland, 45147
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20246
        • Novartis Investigative Site
      • Hannover, Tyskland, 30625
        • Novartis Investigative Site
      • Heidelberg, Tyskland, 69120
        • Novartis Investigative Site
      • Kiel, Tyskland, 24105
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Tyskland, 93053
        • Novartis Investigative Site

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

Beskrivelse

Inclusion Criteria:

  • Male or female recipients of solid organ transplants
  • Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
  • Currently on investigational drug everolimus (RAD) therapy

Exclusion Criteria:

  • Inability or unwillingness to comply with immunosuppressive regimen.
  • Pregnancy.
  • History of acute organ rejection within the last 3 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Studieplan

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

Hvordan er studiet utformet?

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis Pharmaceuticals

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.

Datoer for studieregistrering

Først innsendt

6. september 2005

Først innsendt som oppfylte QC-kriteriene

6. september 2005

Først lagt ut (Anslag)

8. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CRAD001A2401
  • 2004-001473-25

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. .

Kliniske studier på Organtransplantasjon

Kliniske studier på everolimus (RAD)

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Paraguay

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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