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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 opdateret af: Novartis Pharmaceuticals
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Studieoversigt

Status

Ikke længere tilgængelig

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Udvidet adgang

Udvidet adgangstype

  • Befolkning af middelstørrelse

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Novartis Investigative Site
      • Darlinghurst, New South Wales, Australien, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australien, 4102
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Novartis Investigative Site
      • Parkville, Victoria, Australien, 3052
        • Novartis Investigative Site
  • Belgien
      • Bruxelles, Belgien, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgien, 1070
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
  • Brasilien
    • MG
      • Belo Horizonte, MG, Brasilien, 30110-934
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brasilien, 90020-090
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brasilien, 04023-900
        • Novartis Investigative Site
      • São Paulo, SP, Brasilien, 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 Føderation
      • Moscow, Den Russiske Føderation, 115446
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 9RT
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, E1 1BB
        • Novartis Investigative Site
      • Manchester, Det Forenede Kongerige, M23 9LT
        • Novartis Investigative Site
      • Salford, Det Forenede Kongerige, M6 8HD
        • Novartis Investigative Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Novartis Investigative Site
      • Birmingham, Alabama, Forenede Stater, 35294-0006
        • Novartis Investigative Site
      • Mobile, Alabama, Forenede Stater, 36617
        • Novartis Investigative Site
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90027
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90095
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90024
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90057
        • Novartis Investigative Site
      • San Diego, California, Forenede Stater, 92103-8745
        • Novartis Investigative Site
      • San Francisco, California, Forenede Stater, 94115
        • Novartis Investigative Site
      • Stanford, California, Forenede Stater, 94304
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Novartis Investigative Site
      • Denver, Colorado, Forenede Stater, 80218
        • Novartis Investigative Site
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Novartis Investigative Site
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0277
        • Novartis Investigative Site
      • Tampa, Florida, Forenede Stater, 33606
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Novartis Investigative Site
      • Atlanta, Georgia, Forenede Stater, 30309
        • Novartis Investigative Site
      • Augusta, Georgia, Forenede Stater, 30912-3140
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Novartis Investigative Site
      • Chicago, Illinois, Forenede Stater, 60637
        • Novartis Investigative Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Novartis Investigative Site
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Novartis Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0293
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Novartis Investigative Site
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Novartis Investigative Site
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Novartis Investigative Site
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0331
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Novartis Investigative Site
      • Saint Louis, Missouri, Forenede Stater, 63104-1314
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • Novartis Investigative Site
    • New Jersey
      • Livingston, New Jersey, Forenede Stater, 07039
        • Novartis Investigative Site
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Novartis Investigative Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Novartis Investigative Site
      • Bronx, New York, Forenede Stater, 10467
        • Novartis Investigative Site
      • Buffalo, New York, Forenede Stater, 14203
        • Novartis Investigative Site
      • New York, New York, Forenede Stater, 10032
        • Novartis Investigative Site
      • Valhalla, New York, Forenede Stater, 10595
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Novartis Investigative Site
      • Greenville, North Carolina, Forenede Stater, 27834
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Novartis Investigative Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Novartis Investigative Site
      • Cleveland, Ohio, Forenede Stater, 44106-5048
        • Novartis Investigative Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Novartis Investigative Site
      • Columbus, Ohio, Forenede Stater, 43205-2696
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19102 2293
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Novartis Investigative Site
      • Charleston, South Carolina, Forenede Stater, 29403
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37212
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Novartis Investigative Site
      • Galveston, Texas, Forenede Stater, 77555-0144
        • Novartis Investigative Site
      • Houston, Texas, Forenede Stater, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, Forenede Stater, 84157
        • Novartis Investigative Site
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Novartis Investigative Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • Novartis Investigative Site
      • Richmond, Virginia, Forenede Stater, 23284
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25301
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Novartis Investigative Site
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Novartis Investigative Site
  • Frankrig
      • Brest, Frankrig, 29200
        • Novartis Investigative Site
      • Créteil, Frankrig, 94010
        • Novartis Investigative Site
      • Grenoble CEDEX, Frankrig, 38000
        • Novartis Investigative Site
      • Le Plessis Robinson, Frankrig, 92350
        • Novartis Investigative Site
      • Lyon, Frankrig, 69437
        • Novartis Investigative Site
      • Monpellier, Frankrig, 34295
        • Novartis Investigative Site
      • Nantes, Frankrig, 44035
        • Novartis Investigative Site
      • Paris, Frankrig, 75010
        • Novartis Investigative Site
      • Paris, Frankrig, 75651
        • Novartis Investigative Site
      • Saint-Etienne, Frankrig, 42055
        • Novartis Investigative Site
      • Toulouse, Frankrig, 31054
        • Novartis Investigative Site
      • Tours, Frankrig, 37044
        • Novartis Investigative Site
      • Vandoeuvre-Les-Nancy, Frankrig, 54511
        • Novartis Investigative Site
      • Villejuif, Frankrig, 94800
        • Novartis Investigative Site
  • Italien
    • MI
      • Milano, MI, Italien, 20162
        • Novartis Investigative Site
      • Milano, MI, Italien, 20122
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italien, 35128
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italien, 06100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italien, 56124
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italien, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italien, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00168
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italien, 53100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italien, 07100
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italien, 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
  • Schweiz
      • Bern, Schweiz, 3010
        • Novartis Investigative Site
      • Zuerich, Schweiz, 8091
        • Novartis Investigative Site
  • Spanien
      • Madrid, Spanien, 28041
        • Novartis Investigative Site
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Madrid, Spanien, 28222
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spanien, 14004
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spanien, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spanien, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spanien, 46026
        • Novartis Investigative Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spanien, 48903
        • Novartis Investigative Site
  • Sydafrika
      • Johannesburg, Sydafrika, 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
  • Tjekkiet
      • Brno, Tjekkiet, 656 91
        • Novartis Investigative Site
      • Hradec Kralove, Tjekkiet, 505 00
        • Novartis Investigative Site
      • Ostrava-Poruba, Tjekkiet, 708 52
        • Novartis Investigative Site
      • Prague 4, Tjekkiet, 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

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

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

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

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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.

Datoer for studieregistrering

Først indsendt

6. september 2005

Først indsendt, der opfyldte QC-kriterier

6. september 2005

Først opslået (Skøn)

8. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRAD001A2401
  • 2004-001473-25

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 Organtransplantation

Kliniske forsøg med everolimus (RAD)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kuwait

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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