En undersøgelse af Guselkumab subkutan terapi hos deltagere med moderat til svær aktiv Crohns sygdom (GRAVITI)
24. september 2026 opdateret af: Janssen Research & Development, LLC
En randomiseret, dobbeltblind, placebokontrolleret, parallelgruppe, multicenterundersøgelse til evaluering af effektiviteten og sikkerheden af Guselkumab subkutan induktionsterapi hos deltagere med moderat til svært aktiv Crohns sygdom
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
350
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Clayton, Australien, 3168
- Monash Health, Monash Medical Centre
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North Mackay, Australien, 4740
- Coral Sea Clinical Research Institute
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Aalst, Belgien, 9300
- OLV Ziekenhuis Aalst
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Brussels, Belgien, 1070
- Hopital Erasme
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Brussels, Belgien, 1000
- CHU Saint-Pierre
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Roeselare, Belgien, 8800
- Algemeen Ziekenhuis Delta
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Banja Luka, Bosnien-Hercegovina, 78000
- University hospital Clinical centre Banja Luka
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Sarajevo, Bosnien-Hercegovina, 71000
- Clinical Center University of Sarajevo
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Sarajevo, Bosnien-Hercegovina, 71000
- Polyclinic Dr. Al-Tawil
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Tešanj, Bosnien-Hercegovina, 74260
- General Hospital Tesanj
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Tuzla, Bosnien-Hercegovina, 75000
- Plava poliklinika Tuzla
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Zenica, Bosnien-Hercegovina, 72000
- Cantonal Hospital Zenica
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Botucatu, Brasilien, 18608-025
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, Brasilien, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Brasília, Brasilien, 72145 450
- Chronos Clinica Medica Ltda
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Campinas, Brasilien, 13060-904
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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Curitiba, Brasilien, 80430-180
- CDC - Centro Digestivo de Curitiba
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Fortaleza, Brasilien, 60430-370
- Universidade Federal Do Ceara
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Jaú, Brasilien, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Macaé, Brasilien, 27910-020
- Cliged
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Natal, Brasilien, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Passo Fundo, Brasilien, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Brasilien, 90035-003
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, Brasilien, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasilien, 90160-092
- Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto Alegre, Brasilien, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Recife, Brasilien, 51011040
- Hospital das Clinicas - Universidade Federal de Pernambuco
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Salvador, Brasilien, 40110-060
- Universidade Federal da Bahia - Hospital Professor Edgard Santos
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Salvador, Brasilien, 40150150
- SER - Servicos Especializados em Reumatologia da Bahia
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Santo André, Brasilien, 09080-110
- Pesquisare Saude
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Santos, Brasilien, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São Bernardo do Campo, Brasilien, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasilien, 15015-110
- Kaiser Hospta
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São José do Rio Preto, Brasilien, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasilien, 04543-000
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasilien, 03325-050
- BR TRIALS Ensaios Clinicos e Consultoria Ltda
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São Paulo, Brasilien, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, Brasilien, 04543-011
- Hepatogastro
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Teresina, Brasilien, 64049-550
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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Votuporanga, Brasilien, 15501 405
- Integral Centro de Pesquisas Clinicas
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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North Bay, Ontario, Canada, P1B 2H3
- North Bay Dermatology Centre
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Esbjerg, Danmark, 6700
- Sydvestjysk Sygehus
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Hilleroed, Danmark, 3400
- Nordsjaellands Hospital - Hillerod
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Alabama
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Dothan, Alabama, Forenede Stater, 36305
- Digestive Health Specialists of the Southeast
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Arizona
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Chandler, Arizona, Forenede Stater, 85224-1636
- Advanced Gastro P.C
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Scottsdale, Arizona, Forenede Stater, 85260
- Reliance Research
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205-6414
- Moore Clinical Trials, LLC
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Little Rock, Arkansas, Forenede Stater, 72223
- Central Arkansas Veterans Healthcare System
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California
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Anaheim, California, Forenede Stater, 92805
- Clinnova Research
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Lancaster, California, Forenede Stater, 93534
- Om Research LLC
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Lancaster, California, Forenede Stater, 93534
- Om Research LLC 1
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Los Alamitos, California, Forenede Stater, 90720
- United Gastroenterologists
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Los Angeles, California, Forenede Stater, 90048
- Paul Wallace MD
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Pasadena, California, Forenede Stater, 77505-3950
- Digestive System Healthcare
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San Diego, California, Forenede Stater, 92103
- Clinical Applications Laboratories, Inc
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San Diego, California, Forenede Stater, 92103-2120
- Northshore Gastroenterology Research, LLC
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Santa Maria, California, Forenede Stater, 93454
- Santa Maria Gastroenterology
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Walnut Creek, California, Forenede Stater, 94598
- Clinical Research of California
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Colorado
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Grand Junction, Colorado, Forenede Stater, 81505-1027
- Amel Med LLC Research
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Western Connecticut Health Network/Danbury Hospital
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Florida
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Clearwater, Florida, Forenede Stater, 33762-5323
- Gastroenterology Associates of SW Florida
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Coconut Creek, Florida, Forenede Stater, 33066
- Pioneer Research Solutions Inc.
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DeBary, Florida, Forenede Stater, 32713
- Omega Research Consultants
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Hialeah, Florida, Forenede Stater, 33016
- Harmony Medical Research Institute, Inc.
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Kissimmee, Florida, Forenede Stater, 34741
- Central Florida Gastro Research
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Miami, Florida, Forenede Stater, 33155
- Community Research Foundation, Inc.
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Naples, Florida, Forenede Stater, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, Forenede Stater, 32803-1853
- Center for Digestive Health
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Orlando, Florida, Forenede Stater, 32819
- Central Florida Internists
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St. Petersburg, Florida, Forenede Stater, 33705
- Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- Agile Clinical Research Trials, LLC
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Atlanta, Georgia, Forenede Stater, 30224
- Atlanta Gastroenterology Specialists, PC
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Decatur, Georgia, Forenede Stater, 30033
- Atlanta Center For Gastroenterology
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Macon, Georgia, Forenede Stater, 31201
- Gastroenterolgy Associates of Central GA
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Roswell, Georgia, Forenede Stater, 30076-4943
- Gastroenterology Consultants
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- USF Asthma, Allergy, Immunology Clinical Research Unit
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Idaho Falls, Idaho, Forenede Stater, 83404
- Grand Teton Research Group, PLLC
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Illinois
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Oakbrook Terrace, Illinois, Forenede Stater, 60618
- Lemah Creek Clinical Research
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Kansas
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Kansas City, Kansas, Forenede Stater, 66103-2937
- University of Kansas Medical Center
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Leawood, Kansas, Forenede Stater, 66211
- BVL Clinical Research
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Digestive Health Center
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Kentucky
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Crestview Hills, Kentucky, Forenede Stater, 41017
- Tri-State Gastroenterology Assoc
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Louisiana
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Marrero, Louisiana, Forenede Stater, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202-2102
- Institute for Digestive Health and Liver Disease
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Glen Burnie, Maryland, Forenede Stater, 21061
- Woodholme Gastroenterology Associates
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Massachusetts
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Chelmsford, Massachusetts, Forenede Stater, 01824
- Digestive Health Specialists PC
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South Dartmouth, Massachusetts, Forenede Stater, 02747
- FC Research, LLC
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Michigan
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Chesterfield, Michigan, Forenede Stater, 48047
- Clinical Research Institute of Michigan, LLC
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Livonia, Michigan, Forenede Stater, 48152
- Detroit Clinical Research Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, Forenede Stater, 11203
- SUNY Downstate Medical Center
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Jackson Heights, New York, Forenede Stater, 11372
- Smart Medical Research
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Middletown, New York, Forenede Stater, 10941
- Crystal Run Healthcare LLP
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New York, New York, Forenede Stater, 10075
- New York Gastroenterology Associates
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North Massapequa, New York, Forenede Stater, 11758
- DiGiovanna Institute for Medical Education & Research
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Queens, New York, Forenede Stater, 11375
- A1 Clinical Network
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
- Carolinas Medical Center
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Charlotte, North Carolina, Forenede Stater, 28277
- Onsite Clinical Solutions
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Greenville, North Carolina, Forenede Stater, 27834
- Carolina Research
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Gastroenterology Associates of the Piedmont, P.A.
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Ohio
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Columbus, Ohio, Forenede Stater, 43214
- Central Ohio Endoscopy Center LLC
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Dayton, Ohio, Forenede Stater, 45440
- Dayton Gastroenterology, Inc
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Mentor, Ohio, Forenede Stater, 44060
- Great Lakes Gastroenterology
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Health Science Center
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Integris Baptist Office
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Central Sooner Research
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Tulsa, Oklahoma, Forenede Stater, 74137-7061
- Essential Medical Research
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Oregon
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Portland, Oregon, Forenede Stater, 97220-9428
- The Oregon Clinic
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Pennsylvania
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Frontier Clinical Research
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- Gastroenterology Associates P.A.
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Carolina Health Specialists
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Texas
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Lubbock, Texas, Forenede Stater, 79424
- West Texas Clinical Research
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Richmond, Texas, Forenede Stater, 77407
- Victoria Gastroenterology
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San Antonio, Texas, Forenede Stater, 78229
- Gastroenterology Clinic Of San Antonio P A
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San Antonio, Texas, Forenede Stater, 78232
- Wellness Clinical Research
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Southlake, Texas, Forenede Stater, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, Forenede Stater, 75701
- Digestive Health Specialists of Tyler
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Utah
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Salt Lake City, Utah, Forenede Stater, 84124
- Care Access Research- Salt Lake City
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Virginia
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Burke, Virginia, Forenede Stater, 22015
- Burke Internal Medicine and Research
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Chesapeake, Virginia, Forenede Stater, 23320
- Gastroenterology Associates of Tidewater
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Bayonne, Frankrig, 64100
- Centre Hospitalier de la Cote Basque
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Besançon, Frankrig, 25000
- CHRU Besancon Hopital Jean Minjoz
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Colombes, Frankrig, 92701
- Hopital Louis Mourier
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Nantes, Frankrig, 44093
- CHU de Nantes hotel Dieu
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Nice, Frankrig, 06202
- CHU de Nice Hopital de l Archet
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Paris, Frankrig, 75877
- Hôpital Bichat
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Pierre-Bénite, Frankrig, 69495
- Hospices Civils de Lyon HCL
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Reims, Frankrig, 51092
- Hôpital Robert Debré
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Saint-Priest-en-Jarez, Frankrig, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, Frankrig, 67098
- CHRU Strasbourg
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Toulouse, Frankrig, 31059
- CHU Rangueil
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Amsterdam, Holland, 1091 AC
- Onze Lieve Vrouwe Gasthuis
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Rotterdam, Holland, 3045 PM
- Sint Franciscus Gasthuis
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Tilburg, Holland, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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Afula, Israel, 1834111
- Haemek Medical Center
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Beersheba, Israel, 84101
- Soroka University Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tzrifin, Israel, 70300
- Assaf Harofeh Medical Center
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Bologna, Italien, 40138
- Policlinico Sant'Orsola Malpighi
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Milan, Italien, 20132
- Istituto Clinico Humanitas Rozzano, IRCCS
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Roma, Italien, 168
- Policlinico Universitario Agostino Gemelli
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Roma, Italien, 00128
- Università Campus Biomedico di Roma
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Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
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Chūōku, Japan, 1040061
- Ginza central clinic
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Fukui-ken, Japan, 910-8526
- Fukui Prefectural Hospital
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japan, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Fukuyama, Japan, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Gamagōri, Japan, 443-8501
- Gamagori City Hospital
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Gunma, Japan, 371-0034
- Gunma University Hospital
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Hachinohe, Japan, 031-8555
- Hachinohe City Hospital
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Hamamatsu, Japan, 431 3192
- Hamamatsu University Hospital
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Hamamatsu, Japan, 432-8061
- Matsuda Hospital
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Higashi-Ibaraki, Japan, 311-3193
- National Hospital Organization Mito Medical Center
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Hiroshima, Japan, 737-8505
- Kure Kyosai Hospital
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Iizuka-shi, Japan, 820-8505
- National Hospital Organization Shikoku Cancer Center
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Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kagoshima, Japan, 892-0843
- Kagoshima IBD Gastroenterology Clinic
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Kashiwa, Japan, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kitakyushu, Japan, 800-0229
- Kyushu Rosai Hospital
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Kobe, Japan, 650 0017
- Kobe University Hospital
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Kofu, Japan, 400-8506
- Yamanashi Prefectural Central Hospital
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Koshigaya, Japan, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Japan, 839-0809
- Hidaka Coloproctologic Clinic
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Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Kyoto, Japan, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
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Morioka, Japan, 020-8505
- Iwate Medical University Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Nagoya, Japan, 460-0022
- Yokoyama IBD Clinic
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Nakagami-gun, Japan, 901-2132
- University of the Ryukyus Hospital
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Niigata, Japan, 951 8520
- Niigata University Medical And Dental Hospital
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Nishinomiya, Japan, 663-8014
- Nishinomiya Municipal Central Hospital
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Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, Japan, 558-8558
- Osaka General Medical Center
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Osaka, Japan, 543-8555
- Japanese Red Cross Osaka Hospital
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Osaka, Japan, 530-0011
- Kinshukai Infusion Clinic
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Japan, 981-3213
- Takagi Clinic
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Sunto-gun, Japan, 411-8611
- National Hospital Organization Shizuoka Medical Center
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Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
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Toyota, Japan, 470-0396
- Toyota Kosei Hospital
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Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
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Ōita, Japan, 870-0033
- Oita Red Cross Hospital
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Ōtsu, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Amman, Jordan, 11183
- Khalidi Hospital and Medical Center
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Amman, Jordan, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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Amman, Jordan, 11196
- Istiklal Hospital
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Amman, Jordan, 1184
- Abdali Hospital
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Irbid, Jordan, 21110
- Irbid Specialty Hospital
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Irbid, Jordan, 22110
- Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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Bengbu, Kina, 233004
- The Affiliated Hospital of Bengbu Medical College
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Changsha, Kina, 410011
- The second Xiangya Hospital of Central South University
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Changzhou, Kina, 213004
- Changzhou No 2 Peoples Hospital
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Chengdu, Kina, 610041
- West China Hospital Sichuan University
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Chongqing, Kina, 400013
- Chongqing Medical University
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Foshan, Kina, 528010
- The First People's Hospital of Foshan
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Fuzhou, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
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Ganzhou, Kina, 341000
- First Affiliated Hospital of Gannan Medical University
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Guangzhou, Kina, 510180
- Guangzhou First Municipal People's Hospital
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Guangzhou, Kina, 510080
- Guangdong Provincial People's Hospital
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Guangzhou, Kina, 510260
- Guangzhou Medical University
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Hangzhou, Kina, 310006
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
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Nanchang, Kina, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital
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Nanjing, Kina, 210006
- Nanjing 1st Hospital
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Quanzhou, Kina, 362002
- The First Hospital of Quanzhou
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Shanghai, Kina, 200040
- Huashan Hospital Fudan University
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Shanghai, Kina, 200120
- Shanghai East Hospital
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Shenyang, Kina, 110022
- Shengjing Hospital Of China Medical University
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Suzhou, Kina
- The first affiliated hospital of suzhou University
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Wuxi, Kina, 214023
- Wuxi People s Hospital
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Yangzhou, Kina, 225001
- Yangzhou First People's Hospital
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Zhuzhou, Kina, 412007
- ZhuZhou Central Hospital
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Bjelovar, Kroatien, 43000
- Opca bolnica Bjelovar
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Split, Kroatien, 21000
- University Hospital Center Split
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Zadar, Kroatien, 23000
- Opca bolnica Zadar
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Zagreb, Kroatien, 10000
- Poliklinika Solmed
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-
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Kaunas, Litauen, 44307
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
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Vilnius, Litauen, LT-08661
- Vilnius University Hospital Santaros Klinikos, Public Institution
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-
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Johor Bharu, Malaysia, 80100
- Hospital Sultanah Aminah
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Kota Bharu, Malaysia, 16150
- Hospital University Sains Malaysia
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Kota Kinabalu, Malaysia, 88586
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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-
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Dunedin, New Zealand, 9016
- Dunedin Hospital
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Bialystok, Polen, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
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Bydgoszcz, Polen, 85 231
- NZOZ Centrum Medyczne KERmed
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Chojnice, Polen, 89-600
- Centrum Medyczne Lukamed
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Chojnice, Polen, 89 600
- Centrum Medyczne Lukamed Sp z o o
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Chrzanów, Polen, 32-500
- Sahlgrenska University Hospital
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Knurów, Polen, 44 190
- MZ Badania Slowik Zymla Spolka jawna
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Krakow, Polen, 30 149
- Malopolskie Centrum Kliniczne
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Krakow, Polen, 30 363
- Centrum Medyczne Plejady
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Krakow, Polen, 31 637
- Centrum Medyczne ProMiMed
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Lodz, Polen, 90-752
- IP Clinic Sp. z o.o.
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Lodz, Polen, 91 034
- Centrum Medyczne Med Gastr
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Lodz, Polen, 90-644
- AmiCare Centrum Medyczne
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Lublin, Polen, 20-412
- ETG Lublin
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Lublin, Polen, 20 582
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
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Nowy Targ, Polen, 34 400
- Allmedica
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Olsztyn, Polen, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Opole, Polen, 45-819
- Twoja Przychodnia 1
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Piotrkow Trybunalski, Polen, 97 300
- Centrum Medyczne
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Poznan, Polen, 60 309
- EMC Instytut Medyczny SA PL CERTUS
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Poznan, Polen, 61 441
- Synexus Polska Sp z o o
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Poznan, Polen, 61 324
- Twoja Przychodnia
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Rzeszów, Polen, 35-326
- Centrum Medyczne Medyk
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Skorzewo, Polen, 60-185
- Centrum Medyczne Promed
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Sopot, Polen, 81-756
- Endoskopia Sp z o.o.
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Sosnowiec, Polen, 41-200
- Kiepury Clinic
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Straszów, Polen, 28 200
- KO Med Centrum Medyczne
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Szczecin, Polen, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, Polen, 71-685
- Sonomed Sp. z o.o.
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Torun, Polen, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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Tychy, Polen, 43-100
- H-T Centrum Medyczne Endoterapia
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Warsaw, Polen, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw, Polen, 02 653
- Endoterapia
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Warsaw, Polen, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
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Warsaw, Polen, 02 798
- Medical Concierge Centrum Medyczne
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Warsaw, Polen, 03 580
- NZOZ Vivamed
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Warsaw, Polen, 03-712
- Gabinety Lekarskie Bodyclinic
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Warsaw, Polen, 04-501
- IBD Point Profesor Kierkus
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Wierzchosławice, Polen, 33-122
- Centrum Zdrowia Tuchow
-
Wroclaw, Polen, 50-556
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
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Wroclaw, Polen, 53 149
- Przychodnia Vistamed
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Wroclaw, Polen, 53 611
- Centrum Medyczne Melita Medical
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Wroclaw, Polen, 50-449
- Centrum Medyczne Melita Medical 2
-
Włocławek, Polen, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
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Zamość, Polen, 22-400
- Pro Life Medica Sp z o o ETG Zamosc
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-
-
-
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Banská Bystrica, Slovakiet, 974 01
- FNsP F.D.R. Banska Bystrica
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Košice, Slovakiet, 040 13
- ENDOMED s.r.o
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Prešov, Slovakiet, 080 01
- GASTRO I. s.r.o.
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-
-
-
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Gijón, Spanien, 33394
- Hosp. de Cabuenes
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Huelva, Spanien, 21005
- Hosp. Gral. Juan Ramon Jimenez
-
Huelva, Spanien, 21002
- Hosp. Gral. Juan Ramon Jimenez 1
-
Madrid, Spanien, 28031
- Hosp. Univ. Infanta Leonor
-
Seville, Spanien, 41009
- Hosp. Virgen Macarena
-
Vigo, Spanien, 36213
- Hosp. Alvaro Cunqueiro
-
Villajoyosa, Spanien, 03570
- Hosp. de La Marina Baixa
-
-
-
-
-
Busan, Sydkorea, 41404
- Kyungpook National University Chilgok Hospital
-
Busan, Sydkorea, 48108
- Inje University Haeundae Paik Hospital
-
Busan, Sydkorea, 49267
- Kosin University Gospel Hospital
-
Busan, Sydkorea, 602739
- DongA Medical Center
-
Daegu, Sydkorea, 42415
- Yeungnam University Medical Center
-
Daejeon, Sydkorea, 34943
- The Catholic University of Korea Seoul St.Mary's Hospital
-
Dongdaemun-gu, Sydkorea, 02447
- Kyung Hee University Hospital
-
Goyang-si, Sydkorea, 10326
- Dongguk University Ilsan Hospital
-
Gwangju, Sydkorea, 61469
- Chonnam National University Hospital
-
Gyeonggi-do, Sydkorea, 13496
- CHA Bundang Medical Center, CHA University
-
Gyeonggi-do, Sydkorea, 16247
- The Catholic university of Korea, St. Vincent's Hospital
-
Seoul, Sydkorea, 06351
- Samsung Medical Center
-
Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sydkorea, 03722
- Yonsei University College of Medicine
-
Seoul, Sydkorea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Suwon, Sydkorea, 16499
- Ajou University Hospital
-
Wŏnju, Sydkorea, 26426
- Wonju Christian Hospital
-
Yangch’ŏn-gu, Sydkorea, 07985
- Ewha Womans University Mokdong Hospital
-
-
-
-
-
Kaoshiung, Taiwan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital, Division of Infectious Diseases
-
Taipei, Taiwan, 110301
- Taipei Medical University
-
Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
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Brno, Tjekkiet, 636 00
- Fakultni nemocnice Brno
-
Hradec Králové, Tjekkiet, 500 05
- Fakultni nemocnice Hradec Kralove
-
Kladno, Tjekkiet, 27259
- Oblastni nemocnice Kladno a.s.
-
Prague, Tjekkiet, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Slaný, Tjekkiet, 274 01
- Nemocnice Slany
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
-
Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe University Hospital
-
Ankara, Tyrkiet (Türkiye), 06560
- Gazi University Medical Faculty
-
Istanbul, Tyrkiet (Türkiye), 34349
- Acibadem Fulya Hospital
-
Izmir, Tyrkiet (Türkiye), 35040
- Ege Universitesi Tip Fakultesi
-
Mersin, Tyrkiet (Türkiye), 33343
- Mersin University Medical Faculty
-
Samsun, Tyrkiet (Türkiye), 55420
- Ondokuz Mayis University
-
Zonguldak, Tyrkiet (Türkiye), 67000
- Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
-
-
-
Berlin, Tyskland, 14050
- DRK Kliniken Westend
-
Berlin, Tyskland, 14163
- Krankenhaus Waldfriede Mitte
-
Berlin, Tyskland, 10117
- Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
-
Berlin, Tyskland, 10318
- CED Studienzentrum Karlshorst
-
Braunschweig, Tyskland, 38126
- Staedtisches Klinikum Braunschweig
-
Cologne, Tyskland, 51103
- Evangelisches Krankenhaus Kalk
-
Dachau, Tyskland, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
-
Duisburg, Tyskland, 47055
- MVZ Sanaklinikum Duisburg
-
Halle, Tyskland, 6108
- Studiengesellschaft Mitteldeutschland GmbH
-
Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
-
Jerichow, Tyskland, 39319
- Praxisgemeinschaft Jerichow
-
Mannheim, Tyskland, 68167
- Universitaetsklinikum Mannheim
-
Nordhausen, Tyskland, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
-
-
-
-
-
Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Ungarn, H-1088
- Semmelweis Egyetem
-
Budapest, Ungarn, H-1136
- Pannónia Magánorvosi Centrum Kft
-
Budapest, Ungarn, 1097
- Egyesített Szent István és Szent László Kórház
-
Budapest, Ungarn, 1126
- Mh Egészségügyi Központ
-
Budapest, Ungarn, 1125
- Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
-
Kistarcsa, Ungarn, 2143
- Pest Megyei Flor Ferenc Korhaz
-
Mohács, Ungarn, 7700
- Mohacsi Korhaz
-
Pécs, Ungarn, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
-
Szombathely, Ungarn, H-9700
- Markusovszky Egyetemi Oktatokorhaz
-
-
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
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:
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- Unstable doses of concomitant Crohn's disease therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 2) will be administered by SC injection. |
|
Eksperimentel: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 3) will be administered by SC injection. |
|
Placebo komparator: Group 3: Placebo
Participants will receive placebo injection subcutaneously. |
Placebo will be administered by SC injection. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
Tidsramme: At Week 12
|
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Tidsramme: At Week 12
|
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
At Week 12
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 24
Tidsramme: At Week 24
|
Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 24
|
|
Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
Tidsramme: At Week 12
|
Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score <=1, and stool frequency (SF) mean daily score <=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease. |
At Week 12
|
|
Percentage of Participants Who Achieved Clinical Response at Week 12
Tidsramme: At Week 12
|
Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or CDAI score < 150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
Tidsramme: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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.
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)
Studiestart
19. januar 2022
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
4. juli 2023
Studieafslutning (Anslået)
Studieafslutning
30. oktober 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
17. januar 2022
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
17. januar 2022
Først opslået (Faktiske)
Først opslået
19. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
25. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR109125
- 2020-006165-11 (EudraCT nummer)
- CNTO1959CRD3004 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-504737-41-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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 .