Filgotinib i langsiktig forlengelsesstudie av voksne med ulcerøs kolitt (SELECTIONLTE)
15. september 2026 oppdatert av: Alfasigma S.p.A.
En langsiktig utvidelsesstudie for å evaluere sikkerheten til filgotinib hos personer med ulcerøs kolitt
Hovedmålet med denne studien er å observere den langsiktige sikkerheten til filgotinib hos voksne som har fullført eller oppfylt protokollspesifiserte effektseponeringskriterier i en tidligere Gilead-sponset filgotinibbehandlingsstudie ved ulcerøs kolitt (UC).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1173
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Mar del Plata, Argentina, B7600FZN
- Instituto de Investigaciones Clinicas Mar del Plata
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Quilmes, Argentina, B1878
- Instituto Médico Cer
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New South Wales
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Clayton, New South Wales, Australia, 3168
- Monash Medical Centre
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Darlinghurst, New South Wales, Australia, 2010
- St. Vincent's Hospital Sydney
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital
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Queensland
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Mountain Creek, Queensland, Australia, 4557
- Coastal Digestive Health
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South Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Ltd
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Woodville South, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Footscray, Victoria, Australia, 3011
- Footscray Hospital
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Malvern, Victoria, Australia, 3144
- Cabrini Hospital
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Antwerp, Belgia, 2018
- GZA Ziekenhuizen, campus Sint-Vincentius
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Brussels, Belgia, 1070
- CUB Hopital Erasme
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Leuven, Belgia, 3000
- Universitair Ziekenhuis Leuven
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Liège, Belgia, 4000
- Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
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Pleven, Bulgaria, 5800
- MHAT Sveti Pantaleymon- Pleven OOD
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Veliko Tarnovo, Bulgaria, 5000
- "MDHAT Dr. St.Cherkezov" AD
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Vidin, Bulgaria, 3700
- MHAT "Sveta Petka" AD
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary, Heritage Medical Research Clinic
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- The Gordon and Leslie Diamond Health Care Centre
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Hamilton Health Sciences Corporation, McMaster University Medical Centre
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Vaughan, Ontario, Canada, L4L 4Y7
- Toronto Digestive Disease Associates Inc.
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
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Alabama
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Dothan, Alabama, Forente stater, 36305
- Digestive Health Specialists Of The Southeast
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Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic Arizona
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California
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Long Beach, California, Forente stater, 90822
- VA Long Beach Healthcare System
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Los Angeles, California, Forente stater, 90048
- Cedars Sinai Medical Center
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Colorado
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Lone Tree, Colorado, Forente stater, 80124
- South Denver Gastroenterology, PC
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Connecticut
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Farmington, Connecticut, Forente stater, 06032
- Connecticut GI PC-Research Division
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Florida
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Gainesville, Florida, Forente stater, 32610
- UF Clinical Research Center
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Lakewood Rch, Florida, Forente stater, 34211
- Florida Research Institute
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Miami, Florida, Forente stater, 33136
- University of Miami Crohn's and Colitis Center
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Miami, Florida, Forente stater, 33155
- Cordova Research Institute
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Naples, Florida, Forente stater, 34102
- Gastroenterology Group of Naples
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Port Orange, Florida, Forente stater, 32127
- Advanced Medical Research Center
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Tampa, Florida, Forente stater, 33606
- Tampa General Hospital
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Zephyrhills, Florida, Forente stater, 33540
- Florida Medical Clinic, P.A
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Georgia
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Macon, Georgia, Forente stater, 31201
- Gastroenterology Associates Of Central Georgia, LLC
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Marietta, Georgia, Forente stater, 30060
- Gastrointestinal Specialists of Georgia
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Suwanee, Georgia, Forente stater, 30024
- Atlanta Gastroenterology Specialist, PC
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville, Clinical Trials Unit
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Louisiana
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Monroe, Louisiana, Forente stater, 71201
- Delta Research Partners, LLC
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Shreveport, Louisiana, Forente stater, 71105
- Louisiana Research Center, LLC
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Maryland
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Annapolis, Maryland, Forente stater, 21401
- Investigative Clinical Research
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Chevy Chase, Maryland, Forente stater, 20815
- MGG Group Co., Inc., Chevy Chase Clinical Research
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Columbia, Maryland, Forente stater, 21045
- Gastro Center of Maryland
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Hagerstown, Maryland, Forente stater, 21742
- Meritus Center for Clinical Research
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital - Crohn's and Colitis Center
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Michigan
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Chesterfield, Michigan, Forente stater, 48047
- Clinical Research Institute of Michigan, LLC
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Troy, Michigan, Forente stater, 48098
- Center for Digestive Health Research
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Missouri
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Kansas City, Missouri, Forente stater, 64131
- Kansas City Research Institute
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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New York
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Brooklyn, New York, Forente stater, 11235
- NY Scientific
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Great Neck, New York, Forente stater, 11021
- NYU Langone Long Island Clinical Research Associates
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North Carolina
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Raleigh, North Carolina, Forente stater, 27607
- Carolina's GI Research LLC
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North Dakota
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Fargo, North Dakota, Forente stater, 58103
- Fargo Gastroenterology and Hepatology Clinic
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Consultants for Clinical Research
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Cincinnati, Ohio, Forente stater, 45219
- UC Health Physicians Clifton
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Mentor, Ohio, Forente stater, 44060
- Great Lakes Gastroenterology Research, LLC
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South Carolina
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Orangeburg, South Carolina, Forente stater, 29118
- Gastroenterology Associates of Orangeburg
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rapid City Medical Center
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Gastro One
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Nashville, Tennessee, Forente stater, 37211
- Quality Medical Research
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Nashville, Tennessee, Forente stater, 37212-1375
- Vanderbilt University Medical Center - IBD Clinic
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Texas
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Fort Sam Houston, Texas, Forente stater, 78219
- San Antonio Military Medical Center
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Garland, Texas, Forente stater, 75044
- DHAT Research Institute
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine - Baylor Medical Center
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San Antonio, Texas, Forente stater, 78212
- Clinical Associates in Research Therapeutics of America, LLC
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San Antonio, Texas, Forente stater, 78229
- Gastroenterology Research of San Antonio
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San Marcos, Texas, Forente stater, 78666
- TDDC San Marcos
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Southlake, Texas, Forente stater, 76092
- Texas Digestive Disease Consultants
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The Woodlands, Texas, Forente stater, 77380
- Spring Gastroenterology
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Health System
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Chesapeake, Virginia, Forente stater, 23320
- Gastroenterology Associates of Tidewater
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Richmond, Virginia, Forente stater, 23249
- McGuire DVAMC
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- University of Wisconsin Hospital & Clinics
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Wauwatosa, Wisconsin, Forente stater, 53225
- Allegiance Research Specialists, LLC
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Amiens, Frankrike, 80054
- CHU Amiens Picardie
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Caen, Frankrike, 14033
- CHU de Caen
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Clermont-Ferrand, Frankrike, 63003
- CHU de Clermont-Ferrand - Hopital d'Estaing
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Clichy, Frankrike, 92110
- APHP - Hopital Beaujon - Clichy - Universite Paris VII
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Dijon, Frankrike, 21079
- CHU de Dijon Bourgogne - Hopital Francois Mitterand
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La Tronche, Frankrike, 38700
- CHU Grenoble Alpes
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Le Kremlin-Bicêtre, Frankrike, 94270
- Hopital Universitaire de Bicetre
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Lille, Frankrike, 59000
- Centre Hospitalier Regional Universitaire de Lille
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Marseille, Frankrike, 13915
- Hôpital Nord
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Montpellier, Frankrike, 34295
- CHU de Montpellier-Hopital Saint Eloi
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Nantes, Frankrike, 44093
- CHU Hotel-Dieu
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Nice, Frankrike, 06202
- Hopital de l'Archet 2
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Pessac, Frankrike, 33600
- CHU de Bordeaux - Hopital Haut Leveque
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Pierre-Bénite, Frankrike, 69495
- Centre Hospitalier Universitaire de Lyon Sud
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Rennes, Frankrike, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Saint-Priest-en-Jarez, Frankrike, 42055
- CHU de Saint Etienne - Hopital Nord
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Toulouse, Frankrike, 31059
- CHU de Toulouse - Hopital Rangueil
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Vandœuvre-lès-Nancy, Frankrike, 54511
- CHU de Nancy - Hopital Brabois Adultes
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Batumi, Georgia, 6010
- Unimed Ajara LLC - Batumi Referral Hospital
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Tbilisi, Georgia, 0160
- Medi Club Georgia LLC
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Athens, Hellas, 11527
- General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Princess Margaret Hospital
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Shatin, Hong Kong
- Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
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Ahmedabad, India, 380052
- Kaizen Hospital
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Bangalore, India, 560054
- M S Ramaiah Medical College and Hospital
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Chennai, India, 600035
- Apollo Speciality Hospital
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Coimbatore, India, 641005
- VGM Hospital Institute of Gastroenterology
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Hyderabad, India, 500004
- Gleneagles Global Hospitals
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Hyderabad, India, 500019
- Citizens Specialty Hospital
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Hyderabad, India, 500058
- Centre for Liver Research & Diagnostics
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Jaipur, India, 302001
- SR Kalla Memorial Gastro and General Hospital
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Jaipur, India, 302004
- S.M.S Medical College & Hospitals
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Ludhiana, India, 141001
- Dayanand Medical College & Hospital
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Mangaluru, India, 575001
- Kasturba Medical College (KMC) Hospital
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Mumbai, India, 400022
- Lokmanya Tilak Municipal General Hospital
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Nagpur, India, 440010
- Midas Multispeciality Hospital Pvt. Ltd
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Nagpur, India, 440012
- Suretech Hospital & Research Centre Ltd
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Pune, India, 411001
- Grant Medical Foundation Ruby Hall Clinic
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Rajkot, India, 360002
- Shree Giriraj Multispeciality Hospital
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Secunderabad, India, 500003
- Gandhi Hospital
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Surat, India, 395002
- Surat Institute of Digestive Sciences
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Udupi, India, 576104
- Kasturba Hospital Medical College
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Vadodara, India, 390007
- Sterling Hospital
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Varanasi, India, 221005
- Samvedna Hospital
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Dublin, Irland, 9
- Beaumont Hospital
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Haifa, Israel, 31048
- Bnai Zion Medical Center
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Haifa, Israel, 3109601
- Rambam Medical Health Care Campus
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Castellana Grotte, Italia, 70013
- UOC Gastroenterologia II
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Catanzaro, Italia, 88100
- U.O. Fisiopatologia Digestiva
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Chieti, Italia, 66100
- Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
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Milan, Italia, 20121
- Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
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Padova, Italia, 35128
- UOC Gastroenterologia
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Roma, Italia, 128
- UOC Gastroenterologia ed Endoscopia Digestiva
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Rozzano, Italia, 20089
- Istituto Clinico Humanitas
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Pisa
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Pisa, Pisa, Italia, 56124
- Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
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Bunkyō City, Japan, 113-8519
- Medical Hospital, Tokyo Medical and Dental University
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Chikushino-shi, Japan, 818-8502
- Fukuoka University Chikushi Hospital
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Chūōku, Japan, 060-0033
- Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
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Fukuoka, Japan, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Hachiōji, Japan, 192-0032
- Tokai University Hachioji Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Jonan-ku, Japan, 814-0180
- Fukuoka University Hospital
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Kamakura, Japan, 247-0056
- Ofuna Chuo Hospital
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Kitakyushu-shi, Japan, 802-0077
- Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
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Kofu, Japan, 400-8506
- Yamanashi Prefectural Central Hospital
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Kurume-shi, Japan, 839-0809
- Hidaka Coloproctology Clinic
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Kurume-shi, Japan, 830-0011
- Kurume University Hospital
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Kyoto, Japan, 602-8566
- University Hospital, Kyoto Prefectural University of Medicine
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Minatoku, Japan, 108-8642
- Kitasato University Kitasato Institute Hospital
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Minatoku, Japan, 105-8471
- The Jikei University Hospital
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Mitaka-shi, Japan, 181-8611
- Kyorin University Hospital
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Morioka, Japan, 020-8505
- Iwate Medical University Hospital
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Nagakute-shi, Japan, 480-1195
- Aichi Medical University Hospital
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Nishiku, Japan, 950-1104
- Saiseikai Niigata Daini Hospital
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine College Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 545-8586
- Osaka City University Hospital
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Osaka, Japan, 579-8056
- Wakakusa-Daiichi Hospital
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Osaka, Japan, 530-0011
- Kinshukai Infusion Clinic
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Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan
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Saga, Japan, 849-8501
- Saga University Hospital
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Sagamihara, Japan, 252-0375
- Kitasato University Hospital,THE KITASATO INSTITUTE
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Saitama, Japan, 336-0963
- Tokito Clinic
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Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Japan, 983-8520
- National Hospital Organization Sendai Medical Center
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Shinjuku-ku, Japan, 169-0073
- Tokyo Yamate Medical Center
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Takamatsu, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Takasaki-shi, Japan, 3700829
- National Hospital Organization Takasaki General Medical Center
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Takatsuki, Japan, 569-8686
- Osaka Medical College Hospital
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Toyota-shi, Japan, 470-1219
- Ieda Hospital
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Wakayama, Japan, 641-8509
- Wakayama Medical University Hospital
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Yokohama, Japan, 220-0045
- Colo-proctology Center Matsushima Clinic
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Ōita, Japan, 870-0823
- Ishida IBD Clinic
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Ōtsu, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japan, 8528501
- Nagasaki University Hospital
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Osaka
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital
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Zagreb, Kroatia, 10000
- University Hospital Center Zagreb
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Zagreb, Kroatia, 10000
- Clinical Hospital Dubrava
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George Town, Malaysia, 10990
- Hospital Pulau Pinang
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Kota Kinabalu, Malaysia, 88586
- Hospital Queen Elizabeth
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-
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Cuautitlán Izcalli, Mexico, 54750
- PCR-Phylasis Clinicas Research S. de R.L. de C.V.
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Amsterdam, Nederland, 1100
- Academic Medical Center (AMC)
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Apeldoorn, Nederland, 7334
- Gelre Hospital
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Utrecht, Nederland, 3584 CX
- University Medical Center Utrecht
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Grafton, New Zealand, 1023
- Auckland City Hospital
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Newtown, New Zealand, 6021
- Wellington Hospital
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Tauranga, New Zealand, 3112
- Bay of Plenty District Health Board - Tauranga Hospital
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Bialystok, Polen, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
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Bydgoszcz, Polen, 85-681
- Gabinet Lekarski Janusz Rudzinski
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Bydgoszcz, Polen, 85-079
- VITAMED Galaj i Cichomski spólka jawna
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Częstochowa, Polen, 42-217
- NZOZ INTER-MED, Centrum Endoskopowe
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Katowice, Polen, 40-659
- Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
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Krakow, Polen, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
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Krakow, Polen, 31-501
- Krakowskie Centrum Medyczne Sp. z o.o
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Ksawerów, Polen, 95-054
- Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
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Lodz, Polen, 90-302
- Santa Familia, Centrum Badan, Profilaktyki i Leczenia
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Piaseczno, Polen, 05-500
- Centrum Innowacyjnych Terapii Sp. z o.o.
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Poznan, Polen, 60-848
- Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
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Rzeszów, Polen, 35-301
- Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
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Sopot, Polen, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Polen, 71-434
- Twoja Przychodnia-Szczecinskie Centrum Medyczne
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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 Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
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Warsaw, Polen, 00-635
- Centrum Zdrowia MDM
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Warsaw, Polen, 03-712
- Bodyclinic
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Warsaw, Polen, 02-507
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
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Warsaw, Polen, 03-580
- Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
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Wroclaw, Polen, 52-416
- Centrum Medyczne Oporow
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Guimarães, Portugal, 4835-044
- Hospital da Senhora da Oliveira Guimaraes, E.P.E.
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao, EPE
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Bucharest, Romania, 010719
- MedLife, Gastroenterologie
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Bucharest, Romania, 020125
- Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
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Oradea, Romania, 410066
- Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
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Timișoara, Romania, 300002
- Cabinet Particular Policlinic Algomed SRL
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Chelyabinsk, Russland, 454076
- State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
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Irkutsk, Russland, 669079
- State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
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Moscow, Russland, 115446
- Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
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Moscow, Russland, 127015
- State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
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Moscow, Russland, 129110
- State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
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Nizhny Novgorod, Russland, 603126
- State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
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Novosibirsk, Russland, 630087
- State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
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Novosibirsk, Russland, 630084
- State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
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Saint Petersburg, Russland, 191015
- Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
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Saint Petersburg, Russland, 193163
- "Riat" LLC
-
Saint Petersburg, Russland, 196143
- "Scientific Research Centre ECO-safety" LLC
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Saratov, Russland, 410053
- State Healthcare Institution "Regional Clinical Hospital"
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Smolensk, Russland, 214019
- Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
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Tyumen, Russland, 625026
- Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
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Belgrade, Serbia, 3810-972
- Zvezdara University Medical Center
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Singapore, Singapore, 169608
- Singapore General Hospital
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Nitra, Slovakia, 950 01
- KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
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Barcelona, Spania, 08022
- Centro Medico Teknon
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Madrid, Spania, 28040
- Hospital Clinico San Carlos
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Madrid, Spania, 28942
- Hospital Universitario de Fuenlabrada
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Oviedo, Spania, 33006
- Hospital Universitario Central de Asturias
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Seville, Spania, 41013
- Hospital Universitario Virgen del Rocío
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Bury, Storbritannia, BL9 7TD
- The Pennine Acute Hospitals NHS Trust
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Cambridge, Storbritannia, CB2 0QQ
- Cambridge University Hospital NHS Foundation Trust
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Derby, Storbritannia, DE22 3NE
- Royal Derby Hospital
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Edinburgh, Storbritannia, EH4 2XU
- NHS Lothian
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Glasgow, Storbritannia, G51 4TF
- Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
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Glasgow, Storbritannia, G52 3NQ
- NHS Greater Glasgow and Clyde
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High Wycombe, Storbritannia, HP11 2TT
- Wycombe Hospital
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London, Storbritannia, W2 1NY
- Imperial College Healthcare NHS Trust, St Mary's Hospital
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Nottingham, Storbritannia, NG7 2UH
- Biomedical Research Unit
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Oxford, Storbritannia, OX3 9DU
- Oxford University Hospitals NHS Trust
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Prescot, Storbritannia, L35 5DR
- St Helens and Knowsley Teaching Hospitals NHS Trust
-
Southampton, Storbritannia, SO16 6YD
- Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
-
-
Norfolk
-
Norwich, Norfolk, Storbritannia, NR4 7UY
- Norfolk and Norwich University Hospital NHS Foundation Trust
-
-
-
-
-
Bern, Sveits, 3012
- Gastroenterologische Praxis Balsiger, Seibold und Partner
-
Zurich, Sveits, 8091
- Universitätsspital Zürich
-
-
-
-
-
Malmö, Sverige, SE-205-02
- Skane University Hospital
-
Stockholm, Sverige, 182 88
- Danderyd University Hospital Corp
-
Uppsala, Sverige, 75185
- Akademiska Sjukhuset
-
-
-
-
-
Busan, Sør -Korea, 49241
- Pusan National University Hospital
-
Daegu, Sør -Korea, 42415
- Yeungnam University Hospital
-
Seoul, Sør -Korea, 05505
- Asan Medical Center
-
Seoul, Sør -Korea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sør -Korea, 03722
- Yonsei University Health System, Severance Hospital
-
Seoul, Sør -Korea, 130-872
- Kyung Hee University Hospital
-
Seoul, Sør -Korea, 06351
- Division of Gastroenterology, Department of Medicine, Samsung Medical Center
-
Wŏnju, Sør -Korea, 220-701
- Yonsei University Wonju Severance Christian Hospital
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Sør -Korea, 16247
- The Catholic University of Korea, St. Vincent's Hospital
-
-
-
-
-
Cape Town, Sør-Afrika, 7500
- Dr MJ Prins
-
Johannesburg, Sør-Afrika, 1619
- Peermed Clinical Trial Centre
-
-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 10449
- Mackay Memorial Hospital, Taipei
-
Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
-
-
-
-
-
Hradec Králové, Tsjekkia, 500 12
- Hepato-Gastroenterology HK, s.r.o.
-
Mladá Boleslav, Tsjekkia, 293 01
- Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
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Prague, Tsjekkia, 130 00
- G.E.P. Clinic, s r.o.
-
Prague, Tsjekkia, 190 00
- ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
-
-
-
-
-
Berlin, Tyskland, 13353
- Charité - Universitätsmedizin Berlin
-
Berlin, Tyskland, 10117
- Charite Universitaetsmedizin Berlin
-
Berlin, Tyskland, 14050
- DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
-
Braunschweig, Tyskland, 38126
- Stadtisches Klinikum Braunschweig gGmbH
-
Cologne, Tyskland, 50937
- Universitaetsklinik Koln
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Frankfurt am Main, Tyskland, 60431
- Agaplesion Markus Krankenhaus
-
Freiburg im Breisgau, Tyskland, 79106
- Universitatsklinikum Freiburg
-
Hamburg, Tyskland, 22559
- Asklepios Westklinikum Hamburg
-
Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
-
Herne, Tyskland, 44623
- Gastroenterologische Gemeinschaftspraxis Herne
-
Jena, Tyskland, 07747
- Universitatsklinikum Jena
-
Leipzig, Tyskland, 04103
- EUGASTRO GmbH
-
Lüneburg, Tyskland, 21339
- Klinikum Luneburg
-
Minden, Tyskland, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
-
München, Tyskland, 81377
- Klinikum der Universitat Munchen - Grosshadern
-
Tübingen, Tyskland, 72074
- Universitaetsklinikum Tuebingen
-
Ulm, Tyskland, 89081
- Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
-
-
Schleswig-Holstein
-
Kiel, Schleswig-Holstein, Tyskland, 24105
- Universitatsklinikum Schleswig-Holstein
-
-
-
-
-
Cherkasy, Ukraina, 18000
- Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
-
Chernivtsi, Ukraina, 58000
- Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
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Chernivtsi, Ukraina, 58000
- Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
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Dnipropetrovsk, Ukraina, 49000
- State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
-
Ivano-Frankivsk, Ukraina, 76018
- Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
-
Kharkiv, Ukraina, 61037
- Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
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Kharkiv, Ukraina, 63101
- Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
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Kharkiv, Ukraina, 61039
- L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
-
Kyiv, Ukraina, 01030
- Kyiv City Clinical Hospital No. 18, Proctology Department
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Kyiv, Ukraina, 1103
- Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
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Odesa, Ukraina, 65010
- Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
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Odesa, Ukraina, 65025
- Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
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Ternopil, Ukraina, 46002
- Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
-
Vinnytsia, Ukraina, 21005
- Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
-
Vinnytsia, Ukraina, 21018
- M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
-
Vinnytsia, Ukraina, 21029
- Medical Center LLC "Health Clinic"
-
Zaporizhzhya, Ukraina, 69600
- Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
-
-
-
-
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Budapest, Ungarn, 1097
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
-
Budapest, Ungarn, 1125
- Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
-
Békéscsaba, Ungarn, 5600
- Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
-
Gyöngyös, Ungarn, 3200
- Bugat Pal Korhaz, Belgyogyaszat
-
Mosonmagyaróvár, Ungarn, 9200
- Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
-
-
-
-
-
Innsbruck, Østerrike, 6020
- Universitatsklinik Innsbruck
-
Vienna, Østerrike, 1090
- AKH-Medizinische Universitat Wien
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Viktige inkluderingskriterier:
- Må ha evnen til å forstå og signere et skriftlig informert samtykkeskjema (ICF), som må innhentes før initiering av studieprosedyrer knyttet til denne prøven
- Må ha registrert seg i Gilead-sponset UC-foreldreprotokoll GS-US-418-3898
- Må ha fullført alle nødvendige prosedyrer eller oppfylt protokollspesifiserte effektseponeringskriterier i en tidligere Gilead-sponset filgotinibbehandlingsstudie for UC
- Kvinner i fertil alder må ha en negativ graviditetstest på dag 1
- Mannlige og kvinnelige individer i fertil alder som deltar i heteroseksuelt samleie må godta å bruke protokollspesifiserte prevensjonsmetoder som beskrevet i protokollen for den varigheten som er beskrevet
- Vilje til å avstå fra levende eller svekkede vaksiner under studien og i 12 uker etter siste dose av studiemedikamentet
Nøkkelekskluderingskriterier:
- Kjent overfølsomhet overfor studiemedisinen
- Enhver kronisk medisinsk tilstand (inkludert, men ikke begrenset til, hjerte- eller lungesykdom, alkohol- eller narkotikamisbruk) som etter etterforskerens eller sponsorens oppfatning ville gjøre forsøkspersonen uegnet for studien eller ville hindre overholdelse av studieprotokollen
- Menn eller kvinner med reproduksjonspotensial som ikke er villige til å følge protokollspesifiserte prevensjonsmetoder som definert i deltakerne
- Bruk av forbudte medisiner som beskrevet i protokollen
MERK: Andre protokolldefinerte inkluderings-/eksklusjonskriterier kan gjelde.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Filgotinib 200 mg (blind dosering)
Filgotinib 200 mg + placebo for å matche filgotinib 100 mg i opptil 336 uker
|
Tablett(er) administrert oralt én gang daglig
Andre navn:
Tablett(er) administrert oralt én gang daglig
|
|
Eksperimentell: Filgotinib 100 mg (blind dosering)
Filgotinib 100 mg + placebo for å matche filgotinib 200 mg i opptil 336 uker
|
Tablett(er) administrert oralt én gang daglig
Andre navn:
Tablett(er) administrert oralt én gang daglig
|
|
Placebo komparator: Placebo (blind dosering)
Placebo for å matche filgotinib 200 mg + placebo for å matche filgotinib 100 mg i opptil 336 uker
|
Tablett(er) administrert oralt én gang daglig
|
|
Eksperimentell: Filgotinib 200 mg (åpen etikett)
Filgotinib 200 mg i opptil 336 uker
|
Tablett(er) administrert oralt én gang daglig
Andre navn:
|
|
Eksperimentell: Filgotinib 100 mg (åpen etikett)
Filgotinib 100 mg i opptil 336 uker
|
Tablett(er) administrert oralt én gang daglig
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Generell sikkerhetsprofil for filgotinib evaluert etter andel deltakere som opplever uønskede hendelser og unormale kliniske laboratorietester
Tidsramme: Opptil 336 uker pluss 30 dager
|
Opptil 336 uker pluss 30 dager
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Endring fra baseline i komponenter av Mayo Clinic Score (MCS)
Tidsramme: Baseline og opptil 336 uker
|
Baseline og opptil 336 uker
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Alfasigma Study Director, Alfasigma S.p.A.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Feagan BG, Matsuoka K, Rogler G, Laharie D, Vermeire S, Danese S, Loftus EV Jr, Beales I, Schreiber S, Kim HJ, Faes M, de Haas A, Masior T, Rudolph C, Peyrin-Biroulet L. Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study. Aliment Pharmacol Ther. 2024 Sep;60(5):563-584. doi: 10.1111/apt.18158. Epub 2024 Jul 31.
- Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.
- Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. februar 2017
Primær fullføring (Faktiske)
8. september 2026
Studiet fullført (Faktiske)
8. september 2026
Datoer for studieregistrering
Først innsendt
22. september 2016
Først innsendt som oppfylte QC-kriteriene
22. september 2016
Først lagt ut (Antatt)
26. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GS-US-418-3899
- 2016 (U.S. NIH-stipend/kontrakt)
- 2016-002765-58 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .