En undersøgelse til vurdering af effektiviteten og sikkerheden ved induktionsterapi med RO7790121 hos deltagere med moderat til alvorligt aktiv Crohns sygdom (SIBERITE-2)
23. oktober 2026 opdateret af: Hoffmann-La Roche
En fase III, multicenter, dobbeltblind, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden ved induktionsterapi med RO7790121 hos patienter med moderat til alvorligt aktiv Crohns sygdom
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
425
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Undersøgelse Kontakt Backup
- Navn: Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Studiesteder
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Quilmes, Argentina, B1878DVB
- Rekruttering
- Instituto Medico CER
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San Miguel de Tucumán, Argentina, T4000DPK
- Rekruttering
- CICE 9 de Julio
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New South Wales
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Macquarie Park, New South Wales, Australien, 2109
- Rekruttering
- Macquarie University Hospital
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Wahroonga, New South Wales, Australien, 2076
- Rekruttering
- Sydney Adventist Hospital
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Queensland
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Mackay, Queensland, Australien, 4740
- Trukket tilbage
- Coral Sea Clinical Research Institute
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South Australia
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Adelaide, South Australia, Australien, 5112
- Rekruttering
- Lyell McEwin Hospital
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Victoria
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Footscray, Victoria, Australien, 3011
- Rekruttering
- Footscray Hospital
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Parkville, Victoria, Australien, 3050
- Rekruttering
- Royal Melbourne Hospital
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Brussels, Belgien, 1090
- Rekruttering
- UZ Brussel
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Brussels, Belgien, 1200
- Rekruttering
- Cliniques Universitaires St-Luc
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Brussels, Belgien, 1000
- Rekruttering
- CHU St Pierre (St Pierre)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-000
- Rekruttering
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brasilien, 27258-000
- Rekruttering
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brasilien, 49055-000
- Rekruttering
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brasilien, 17210-190
- Rekruttering
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Rekruttering
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brasilien, 01308-050
- Trukket tilbage
- Hospital Sírio-Libanês
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Panagyurishte, Bulgarien, 4500
- Rekruttering
- Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
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Plovdiv, Bulgarien, 4003
- Rekruttering
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Rekruttering
- Barrie GI Associates
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Brampton, Ontario, Canada, L6S 0E2
- Rekruttering
- GNRR Digestive Clinics and Research Center Inc.
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London, Ontario, Canada, N6K 1M6
- Rekruttering
- LDDI Clinical Trials Inc.
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London, Ontario, Canada, N6A 5A5
- Trukket tilbage
- London Health Sciences Centre Uni Campus
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North YORK, Ontario, Canada, M6A 3B4
- Rekruttering
- Toronto Immune and Digestive Health Institute
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
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Las Condes, Chile, 7560908
- Rekruttering
- Medicina de Precisión - Celerity
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Santiago, Chile, 8330034
- Rekruttering
- Centro de Investigación Clínica UC-CICUC
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Santiago, Chile, 7500000
- Rekruttering
- Medwal
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Bogotá, Colombia, 000472
- Rekruttering
- Hospital Universitario San Ignacio
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Bogotá, Colombia, 111071
- Rekruttering
- Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
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Bogotá, Colombia, 110221
- Trukket tilbage
- Clínica de la Mujer
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Montería, Colombia, 230002
- Rekruttering
- Oncomedica S.A.
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Santander Department
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Piedecuesta, Santander Department, Colombia, 681004
- Rekruttering
- Fundacion Cardiovascular de Colombia - KM 7 Autopista
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Bristol, Det Forenede Kongerige, BS10 5NB
- Rekruttering
- Southmead Hospital
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Bury, Det Forenede Kongerige, BL9 7TD
- Rekruttering
- Fairfield General Hospital
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Llanrhystud, Det Forenede Kongerige, SY23 1ER
- Rekruttering
- Bronglais General Hospital
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London, Det Forenede Kongerige, E1 1FR
- Rekruttering
- Royal London Hospital
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Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
- Rekruttering
- Royal Victoria Infirmary
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Stockport, Det Forenede Kongerige, SK2 7JE
- Aktiv, ikke rekrutterende
- Stepping Hill Hospital
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Alabama
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Dothan, Alabama, Forenede Stater, 36305
- Rekruttering
- Digestive Health Specialists of the Southeast
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Arizona
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Glendale, Arizona, Forenede Stater, 85304
- Rekruttering
- Sun City Clinical Research
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California
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Lancaster, California, Forenede Stater, 93534
- Rekruttering
- Om Research LLC
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Newport Beach, California, Forenede Stater, 92663
- Rekruttering
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
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Pomona, California, Forenede Stater, 91767
- Trukket tilbage
- Empire Clinical Research
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Redwood City, California, Forenede Stater, 94063
- Rekruttering
- Stanford Medicine Outpatient Center
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San Diego, California, Forenede Stater, 92103
- Rekruttering
- Clinical Applications Laboratories, Inc.
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Santa Clarita, California, Forenede Stater, 91355
- Rekruttering
- Amicis Research Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rekruttering
- Peak Gastroenterology Associates
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Florida
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Doral, Florida, Forenede Stater, 33126
- Rekruttering
- J&A Clinical Research
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Lakeland, Florida, Forenede Stater, 33813
- Rekruttering
- Auzmer Research
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Lehigh Acres, Florida, Forenede Stater, 33936
- Rekruttering
- Galenus Group Inc
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- Rejuvaline Medical Research
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- Allied Biomedical Research Institute, Inc
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Miami, Florida, Forenede Stater, 33033
- Rekruttering
- Homestead Associates in Research, Inc.
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Miami Beach, Florida, Forenede Stater, 33141
- Rekruttering
- Miami Beach Clinical Research Center
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Miramar, Florida, Forenede Stater, 33027
- Rekruttering
- Eminat Research Group
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Orlando, Florida, Forenede Stater, 32825
- Rekruttering
- Digestive and Liver Center of Florida
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Port Orange, Florida, Forenede Stater, 32127
- Rekruttering
- Advanced Medical Research Center
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Tampa, Florida, Forenede Stater, 33615
- Rekruttering
- Santos Research Center, CORP
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Forenede Stater, 30310-1495
- Rekruttering
- Morehouse School Of Medicine
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- The University of Chicago
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40206
- Rekruttering
- Robley Rex VA Medical Center
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Louisville, Kentucky, Forenede Stater, 40218
- Rekruttering
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Rekruttering
- Baton Rouge General Medical Center
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Shreveport, Louisiana, Forenede Stater, 71105
- Rekruttering
- Louisiana Research Center - GastroIntestinal Associates
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
- Rekruttering
- Mercy Medical Center
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Chevy Chase, Maryland, Forenede Stater, 20815
- Rekruttering
- FOMAT Medical Research - Chevy Chase Clinical Research
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Massachusetts
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North Worcester, Massachusetts, Forenede Stater, 01655
- Rekruttering
- University of Massachusetts Memorial Medical Center
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Michigan
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Wyoming, Michigan, Forenede Stater, 49519
- Rekruttering
- Gastroenterology Associates of Western Michigan, P.L.C.
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Rekruttering
- Gastrointestinal Associates Research
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Missouri
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Columbia, Missouri, Forenede Stater, 65201-5275
- Rekruttering
- Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Specialists in Gastroenterology
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Rekruttering
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New Jersey
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Moorestown, New Jersey, Forenede Stater, 08057
- Rekruttering
- Virtua Crohns and Colitis Center
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Robert Wood Johnson University Hospital
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New York
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Brooklyn, New York, Forenede Stater, 11215
- Rekruttering
- Ellipsis Research Group
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Fresh Meadows, New York, Forenede Stater, 11366
- Rekruttering
- Intercity Gastroenterology
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Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- NYU Langone Long Island Clinical Research Associates
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The Bronx, New York, Forenede Stater, 10468
- Rekruttering
- James J Peters Veterans Affairs Medical Center
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Utica, New York, Forenede Stater, 13502
- Rekruttering
- Digestive Disease Medicine of Central New York
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
- Rekruttering
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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High Point, North Carolina, Forenede Stater, 27260
- Rekruttering
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Forenede Stater, 45431
- Rekruttering
- Clinical Inquest Center
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02904
- Rekruttering
- University Gastroenterology
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Tennessee
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Cordova, Tennessee, Forenede Stater, 38018
- Rekruttering
- Gastro One
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Nashville, Tennessee, Forenede Stater, 37212-1375
- Rekruttering
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390-8565
- Rekruttering
- University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
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Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- GI Alliance - Fort Worth
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Garland, Texas, Forenede Stater, 75044
- Rekruttering
- GI Alliance
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Houston, Texas, Forenede Stater, 77090
- Rekruttering
- Integrity Advanced Therapeutics PLLC
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Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
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San Antonio, Texas, Forenede Stater, 78212
- Rekruttering
- Carta - Clinical Associates In Research Therapeutics Of America;LLC
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Tyler, Texas, Forenede Stater, 75701
- Rekruttering
- Tyler Research Institute, LLC
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Tyler, Texas, Forenede Stater, 75708
- Rekruttering
- University of Texas Health Center at Tyler
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Webster, Texas, Forenede Stater, 77598
- Rekruttering
- TDDC GI Alliance research Webster
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Virginia
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Richmond, Virginia, Forenede Stater, 23229
- Rekruttering
- GI Alliance-Richmond
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Rekruttering
- Virginia Mason Medical Center
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Washington Gastroenterology
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- Trukket tilbage
- University Physicians and Surgeons Inc, dba Marshall Health
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Chambray-lès-Tours, Frankrig, 37170
- Rekruttering
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Frankrig, 63000
- Rekruttering
- CHU Clermont Ferrand - Hôpital d'Estaing
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Créteil, Frankrig, 94000
- Rekruttering
- Hôpital Henri Mondor
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La Roche-sur-Yon, Frankrig, 85925
- Rekruttering
- CH Dptal Les Oudairies
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Lille, Frankrig, 59037
- Rekruttering
- CHRU de Lille - Hopital Claude Huriez
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Limoges, Frankrig, 87042
- Rekruttering
- Hopital Dupuytren
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Montpellier, Frankrig, 34295
- Rekruttering
- Hopital Saint-Eloi
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Neuilly-sur-Seine, Frankrig, 92200
- Aktiv, ikke rekrutterende
- Institut des MICI, Clinique Ambroise Paré
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Paris, Frankrig, 75475
- Rekruttering
- Hôpital Saint-Louis
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Vandœuvre-lès-Nancy, Frankrig, 54511
- Rekruttering
- Hôpital de Brabois Adultes
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Rhône
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Pierre-Bénite, Rhône, Frankrig, 69310
- Aktiv, ikke rekrutterende
- Centre hospitalier Lyon Sud
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Andhra Pradesh
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Kurnool, Andhra Pradesh, Indien, 518002
- Rekruttering
- Kurnool Medical College
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Gujarat
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Rajkot, Gujarat, Indien, 360005
- Trukket tilbage
- Shree Giriraj Multispeciality Hospital
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Surat, Gujarat, Indien, 395002
- Rekruttering
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, Indien, 395009
- Rekruttering
- Gujarat Gastro and Vascular Hospital
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Kerala
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Kochi, Kerala, Indien, 682041
- Rekruttering
- Amrita Institute of Medical Sciences
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Maharashtra
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Nagpur (urban), Maharashtra, Indien, 440018
- Rekruttering
- MIDAS Multispeciality Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indien, 110029
- Rekruttering
- All India Institute Of Medical Sciences (AIIMS)
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Rajasthan
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Jaipur, Rajasthan, Indien, 302006
- Rekruttering
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, Indien, 302007
- Rekruttering
- SMS Superspeciality Hospital
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Telangana
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Gachibowli, Telangana, Indien, 500032
- Rekruttering
- AIG Hospitals
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Secunderabad, Telangana, Indien, 500003
- Rekruttering
- Yashoda Hospitals
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Secunderabad, Telangana, Indien, 500003
- Rekruttering
- Gandhi Hospital
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West Bengal
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Kolkata, West Bengal, Indien, 700020
- Rekruttering
- Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
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-
-
-
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Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center
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-
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Basilicate
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Matera, Basilicate, Italien, 75100
- Rekruttering
- Ospedale Madonna delle Grazie
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 40138
- Rekruttering
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
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Lazio
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Rome, Lazio, Italien, 00168
- Rekruttering
- Policlinico Universitario Agostino Gemelli
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Rome, Lazio, Italien, 00128
- Rekruttering
- Policlinico Universitario Campus Biomedico Di Roma
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Lombardy
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Brescia, Lombardy, Italien, 25123
- Rekruttering
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italien, 20132
- Rekruttering
- IRCCS Ospedale San Raffaele
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San Donato Milanese (MI), Lombardy, Italien, 20097
- Rekruttering
- I.R.C.C.S Policlinico San Donato
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Veneto
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Negrar, Veneto, Italien, 37024
- Rekruttering
- IRCCS Ospedale Sacro Cuore Don Calabria
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-
-
-
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Beijing, Kina, 100730
- Rekruttering
- Beijing Union Hospital
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Chengdu, Kina, 610072
- Rekruttering
- Sichuan Provincial People's Hospital
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Guangzhou, Kina, 510280
- Rekruttering
- Zhujiang Hospital, Southern Medical University
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Guangzhou, Kina, 510180
- Rekruttering
- Guangzhou First People's Hospital
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Haikou, Kina, 570311
- Rekruttering
- Hainan General Hospital
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Huai'an, Kina
- Rekruttering
- Huai'an First People's Hospital
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Huizhou, Kina
- Rekruttering
- Huizhou First Hospital
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Kunming, Kina, 650032
- Rekruttering
- The First Affilliated Hospital of Kunming Medical University
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Nanchang, Kina, 330008
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
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Shanghai, Kina, 200092
- Rekruttering
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Kina, 200127
- Rekruttering
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, Kina, 110004
- Rekruttering
- Shengjing Hospital of China Medical University
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Shijiazhuang, Kina, 050004
- Rekruttering
- Hebei Medical University - The Second Hospital
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Suzhou, Kina, 215004
- Rekruttering
- The Second Affiliated Hospital of Soochow University
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Xi'an, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiao Tong University
-
Xiamen, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University
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Zhenjiang, Kina, 212001
- Rekruttering
- Affiliated Hospital of Jiangsu University
-
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Jiangxi
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Ganzhou, Jiangxi, Kina, 341000
- Rekruttering
- First Affiliated Hospital of Gannan Medical University
-
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Zhejiang
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Jinhua, Zhejiang, Kina, 321013
- Rekruttering
- Jinhua municipal central hospital
-
-
-
-
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Osijek, Kroatien, 31000
- Rekruttering
- Borzan Polyclinic
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Zagreb, Kroatien, 10000
- Rekruttering
- Clinical Hospital Centre Zagreb
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-
-
-
-
Bia?ystok, Polen, 15-322
- Rekruttering
- Gastromed Kralisz, Romatowski, Stachurska sp.j.
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Bydgoszcz, Polen, 85-231
- Rekruttering
- Medical Center Kermed
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Elblag, Polen, 82-300
- Rekruttering
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Polen, 14-200
- Rekruttering
- Osrodek Badan Klinicznych Bd Research
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Knurów, Polen, 44-190
- Rekruttering
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Polen, 31-513
- Rekruttering
- Centrum Medyczne Promed
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Lodz, Polen, 91-495
- Rekruttering
- Amicare Sp. z o.o. S.K.
-
Lublin, Polen, 20-582
- Rekruttering
- Medrise sp z o.o
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Poznan, Polen, 61-731
- Rekruttering
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Polen, 60-309
- Rekruttering
- EMC Instytut Medyczny SA
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Późna, Polen, 61-441
- Rekruttering
- Gabinety Lekarskie Rivermed
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Sopot, Polen, 81-756
- Rekruttering
- Endoskopia Sp. z o.o.
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Staszów, Polen, 20-200
- Rekruttering
- Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
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Szczecin, Polen, 71-685
- Rekruttering
- Sonomed Sp. z o.o.
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Warsaw, Polen, 00-189
- Rekruttering
- Centrum Zdrowia-MDM
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Warsaw, Polen, 02-679
- Rekruttering
- Medon Clinical Research sp. z o.o
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Warsaw, Polen, 03-580
- Rekruttering
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Polen, 52-210
- Rekruttering
- PlanetMed sp. z o.o.
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-
-
-
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Braga, Portugal, 4710-243
- Rekruttering
- Hospital de Braga
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Lisbon, Portugal, 1649-035
- Rekruttering
- Hospital de Santa Maria
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Porto, Portugal, 4202-451
- Rekruttering
- Hospital de Sao Joao
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Santa Maria da Feira, Portugal, 4520-211
- Rekruttering
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portugal, 3504-509
- Rekruttering
- Hospital Sao Teotonio
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-
-
-
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Manati, Puerto Rico, 00674
- Rekruttering
- Galenus Group Of Puerto Rica Inc
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-
-
-
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Cluj-Napoca, Rumænien
- Rekruttering
- Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
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-
-
-
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Bratislava, Slovakiet, 821 07
- Rekruttering
- ABAWI spol. s r.o.
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Nitra, Slovakiet, 949 01
- Rekruttering
- KM Management spol. s r.o.
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-
-
-
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Madrid, Spanien, 28040
- Rekruttering
- Hospital General Universitario Gregorio Maranon
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Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Clinico Univ. Lozano Blesa
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Madrid
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Alcorcón, Madrid, Spanien, 28922
- Rekruttering
- Fundacion Hospital de Alcorcon
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Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro
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-
-
-
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Daegu, Sydkorea, 42415
- Rekruttering
- Yeungnam University Medical Center
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Gwangju, Sydkorea, 61453
- Rekruttering
- Chosun University Hospital
-
Seoul, Sydkorea, 04763
- Rekruttering
- Hanyang University Seoul Hospital
-
Seoul, Sydkorea, 03312
- Rekruttering
- The Catholic University of Korea Eunpyeong St. Mary's Hospital
-
-
Gyeonggi-do
-
Ansan-si, Gyeonggi-do, Sydkorea, 15355
- Rekruttering
- Korea University Ansan Hospital
-
-
-
-
-
Hradec Králové, Tjekkiet, 500 12
- Rekruttering
- Hepato-Gastroenterologie HK, s.r.o.
-
Ostrava - Poruba, Tjekkiet, 708 52
- Rekruttering
- Fakultni nemocnice Ostrava
-
Prague, Tjekkiet, 170 04
- Rekruttering
- ISCARE a.s.
-
Prague, Tjekkiet, 140 21
- Rekruttering
- Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
-
Ústí nad Labem, Tjekkiet, 401 13
- Rekruttering
- Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
-
-
-
-
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Universitätsklinikum Heidelberg
-
Potsdam, Tyskland, 14467
- Rekruttering
- Klinikum Ernst von Bergmann
-
-
-
-
-
Budapest, Ungarn, 1082
- Rekruttering
- Semmelweis Egyetem
-
Budapest, Ungarn, 1062
- Rekruttering
- Észak-Pesti Centrumkórház-Honvédkórház
-
Budapest, Ungarn, 1066
- Rekruttering
- Geomedical Orvosi Kft
-
Budapest, Ungarn, 1139
- Rekruttering
- Endomedix Kft.
-
Szombathely, Ungarn, 9700
- Rekruttering
- Vas-Oxy Egeszsegugyi Kft
-
-
-
-
-
Linz, Østrig, 4010
- Rekruttering
- Ordensklinikum Linz Barmherzige Schwestern
-
Wels, Østrig, 4600
- Rekruttering
- Klinikum Wels-Grieskirchen
-
-
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
16 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight >= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A 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
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Andre navne:
|
|
Placebo komparator: Placebo
Participants will receive placebo IV followed by afimkibart SC injection. |
Placebo matching IV afimkibart. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Tidsramme: At Week 12
|
Percentage of participants achieving a CDAI score of <150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Response
Tidsramme: At Week 12
|
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of >50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity. |
At Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Tidsramme: Up to 30 Weeks after Baseline
|
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest. |
Up to 30 Weeks after Baseline
|
|
Percentage of Participants with Symptomatic Remission
Tidsramme: At Week 12
|
Percentage of participants with the daily number of liquid or very soft stools <=2.8 and the average of daily abdominal pain scores in the past week <=1, with neither being greater than baseline. |
At Week 12
|
|
Percentage of Participants with Endoscopic Remission
Tidsramme: At Week 12
|
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1. |
At Week 12
|
|
Percentage of Participants with Ulcer-free Endoscopy
Tidsramme: At Week 12
|
Percentage of participants with an SES-CD ulcerated surface subscore of 0. |
At Week 12
|
|
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Tidsramme: Baseline through Week 12
|
Daily average number of liquid or very soft stools over 7 days. |
Baseline through Week 12
|
|
Average of Daily Abdominal Pain Scores in the Past Week (APS)
Tidsramme: Baseline through Week 12
|
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain. |
Baseline through Week 12
|
|
Bowel Urgency
Tidsramme: Baseline to Week 12
|
Bowel urgency from baseline through week 12 and. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe." |
Baseline to Week 12
|
|
Fatigue
Tidsramme: Baseline to Week 12
|
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much." |
Baseline to Week 12
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Tidsramme: Baseline to Week 12
|
Change in IBDQ score from baseline to week 12. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life. |
Baseline to Week 12
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Tidsramme: At Week 12
|
Percentage of participants achieving a CDAI score of <150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Tidsramme: At Week 12
|
Percentage of participants achieving a decrease in SES-CD of >50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity. |
At Week 12
|
|
Percentage of Participants with Clinical Response
Tidsramme: At Week 12
|
Percentage of participants with a decrease >=100 in CDAI from baseline. |
At Week 12
|
|
Percentage of Participants with Symptomatic Response
Tidsramme: At Week 12
|
Percentage of participants with a decrease >=30% in both SF and APS, with neither being greater than baseline. |
At Week 12
|
|
Overall Change in CD Symptoms
Tidsramme: Baseline to Weeks 2, 6 and 12
|
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6 and 12. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse". |
Baseline to Weeks 2, 6 and 12
|
|
Overall Severity in CD Symptoms
Tidsramme: Baseline to Weeks 2, 6 and 12
|
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6 and 12. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe". |
Baseline to Weeks 2, 6 and 12
|
|
Change in General Well-being
Tidsramme: Baseline through Week 12
|
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible. |
Baseline through Week 12
|
|
Presence of Draining Fistulas
Tidsramme: Baseline through Week 12
|
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining. |
Baseline through Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
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)
12. maj 2025
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
30. april 2033
Datoer for studieregistrering
Først indsendt
6. februar 2025
Først indsendt, der opfyldte QC-kriterier
6. februar 2025
Først opslået (Faktiske)
11. februar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GA45332
- 2024-513054-30-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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 .