Clinical trial NCT02914600: Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2016-09-26
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).


Eligibility criteria: Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
* Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
* Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
* Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Key Exclusion Criteria:

* Known hypersensitivity to the study drug
* Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
* Use of prohibited concomitant medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From the First Dose to Week 312
Secondary outcomes:
measure: Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
timeFrame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
measure: Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
timeFrame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
measure: Change From Baseline in CDAI Scores
timeFrame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists Of The Southeast
state: Alabama
city: Sun City
country: United States
facility: Arizona Digestive Health - Sun City
state: Arizona
city: Coronado
country: United States
facility: Southern California Research Center, Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: UC San Diego Health Systems
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Santa Clarita
country: United States
facility: Clearview Medical Research, LLC
state: California
city: Aurora
country: United States
facility: University of Colorado Denver and Hospital
state: Colorado
city: Lone Tree
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Farmington
country: United States
facility: Connecticut GI, PC - Research Division
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Coral Springs
country: United States
facility: Advanced Research, LLC
state: Florida
city: Gainesville
country: United States
facility: UF Clinical Research Center
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Orlando
country: United States
facility: Center for Interventional Endoscopy - Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Gulf Region Clinical Research Institute
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates Of Central Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialist, PC
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Gastroenterology Group - Arlington Heights
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center (Clinic)
state: Illinois
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group - Gurnee
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville, Clinical Trials Unit
state: Kentucky
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital - Crohn's and Colitis Center
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Hospital
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: New York University School of Medicine / NYU Gastroenterology Associates
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Carolina's GI Research LLC
state: North Carolina
city: Fargo
country: United States
facility: Fargo Gastroenterology and Hepatology Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Physicians Clifton
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research LLC
state: Oklahoma
city: Harrisburg
country: United States
facility: Great Lakes Medical Research, LLC
state: Pennsylvania
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - IBD Clinic
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center,
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - McNair Campus
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Marcos
country: United States
facility: TDDC San Marcos
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: The Woodlands
country: United States
facility: Spring Gastroenterology
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC
state: Wisconsin
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos CiRec
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Mountain Creek
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute (Mackay)
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Universitatsklinik Innsbruck
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.
city: Wien
country: Austria
facility: AKH-Medizinische Universitat Wien
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen, campus Sint-Vincentius
city: Bonheiden
country: Belgium
facility: Imelda General Hospital
city: Brussel
country: Belgium
facility: CUB Hopital Erasme
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liege
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
city: Roeselare
country: Belgium
facility: AZ Delta
city: Samokov
country: Bulgaria
facility: Medical Center - Complete Medical Solutions OOD
city: Sliven
country: Bulgaria
facility: Medical Center - "Tsaritsa Yoanna" EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: "MDHAT Dr. St.Cherkezov" AD
city: Vidin
country: Bulgaria
facility: MHAT "Sveta Petka" AD
city: Barrie
country: Canada
facility: Barrie GI Associates
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Clinic
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
city: North York
country: Canada
facility: TIDHI Innovation, Inc.
city: Oakville
country: Canada
facility: ABP Research Services
city: Saskatoon
country: Canada
facility: Royal University Hospital
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Vancouver
country: Canada
facility: The Gordon and Leslie Diamond Health Care Centre
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc.
city: Victoria
country: Canada
facility: Percuro Clinical Research Ltd.
city: Osijek
country: Croatia
facility: University Hospital Center Osijek
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterology HK, s.r.o.
city: Mlada Boleslav
country: Czechia
facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
city: Praha 3
country: Czechia
facility: G.E.P. Clinic, s r.o.
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN
city: Praha 9
country: Czechia
facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty
city: Amiens Cedex 1
country: France
facility: CHU Amiens Picardie
city: Caen Cedex 9
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hopital d'Estaing
city: Clichy
country: France
facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII
city: Créteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Dijon
country: France
facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Kremlin Bicetre
country: France
facility: Hopital Universitaire de Bicetre
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Marseille
country: France
facility: Hopital Nord
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: CHU de Montpellier-Hopital Saint Eloi
city: Nantes
country: France
facility: CHU Hotel-Dieu
city: Nice
country: France
facility: Hopital de l'Archet 2
city: Pessac
country: France
facility: CHU de Bordeaux - Hopital Haut Leveque
city: Pierre-Benite
country: France
facility: Centre Hospitalier Universitaire de Lyon Sud
city: Pringy Cedex
country: France
facility: CH Annecy Genevois - Site d'Annecy
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Saint Priest en Jarez
country: France
facility: CHU de Saint Etienne - Hopital Nord
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Vandoeuvre-les-Nancy Cedex
country: France
facility: CHU de Nancy - Hopital Brabois Adultes
city: Batumi
country: Georgia
facility: Unimed Ajara LLC - Batumi Referral Hospital
city: Tbilisi
country: Georgia
facility: Medi Club Georgia LLC
city: Telavi
country: Georgia
facility: Ltd. Unimed Kakheti - Telavi Referral Hospital
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum Delitzsch
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig gGmbH
city: Dresden
country: Germany
facility: Universitatsklinikum Dresden
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt am Main
country: Germany
facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Praxis fur Gastroenterologie
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Koln
country: Germany
facility: Universitaetsklinik Koln
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Lüneburg
country: Germany
facility: Klinikum Luneburg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Muenchen
country: Germany
facility: Klinikum der Universitat Munchen - Grosshadern
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
city: Athens
country: Greece
facility: Hippokration Hospital of Athens
city: Athens
country: Greece
facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
city: Patra
country: Greece
facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
city: Thessaloniki
country: Greece
facility: Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
city: Budapest
country: Hungary
facility: Szent Margit Korhaz, Gasztroenterológiai Osztály
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz, Belgyogyaszat
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
city: Kochi
country: India
facility: Lakeshore Hospital and Research Centre Ltd
state: Kerala
city: Ahmedabad
country: India
facility: Kaizen Hospital
city: Bangalore
country: India
facility: Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospital
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Coimbatore
country: India
facility: VGM Hospital Institute of Gastroenterology
city: Ernakulam
country: India
facility: Lourdes Hospital
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
city: Hyderabad
country: India
facility: Gleneagles Global Hospital
city: Hyderabad
country: India
facility: Citizens Specialty Hospital
city: Hyderabad
country: India
facility: Centre for Liver Research & Diagnostics
city: Jaipur
country: India
facility: SR Kalla Memorial Gastro and General Hospital
city: Jaipur
country: India
facility: S.M.S Hospital
city: Kolkata
country: India
facility: School of Digestive & Liver Diseases
city: Lucknow
country: India
facility: King George's Medical University
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mangaluru
country: India
facility: Kasturba Medical College (KMC) Hospital
city: Mumbai
country: India
facility: Seth G.S. Medical College & KEM Hospital
city: Mumbai
country: India
facility: S.L. Raheja Hospital (A Fortis Associate)
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt. Ltd
city: Nagpur
country: India
facility: Suretech Hospital & Research Centre Ltd
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pune
country: India
facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
city: Pune
country: India
facility: Universal Hospital
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Secunderabad
country: India
facility: Gandhi Hospital
city: Secunderabad
country: India
facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
city: Udupi
country: India
facility: Kasturba Hospital Medical College
city: Vadodara
country: India
facility: Sterling Hospital
city: Varanasi
country: India
facility: Samvedna Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Wellcome Trust HRB Clinical Research Facility
city: Galway
country: Ireland
facility: University Hospital Galway
city: Afula
country: Israel
facility: Emek Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Health Care Campus
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kefar Sava
country: Israel
facility: Meir MC
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Castellana Grotte
country: Italy
facility: UOC Gastroenterologia II
city: Catanzaro
country: Italy
facility: U.O. Fisiopatologia Digestiva
city: Cento
country: Italy
facility: UOC Medicina Interna
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
city: Firenze
country: Italy
facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Endocsopia Digestiva Centralizzata
city: Modena
country: Italy
facility: UO Gastroenterologia
city: Padova
country: Italy
facility: UOC Gastroenterologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
city: Roma
country: Italy
facility: UOC Gastroenterologia ed Endoscopia Digestiva
city: Roma
country: Italy
facility: UOC di Gastroenterologia ed Endoscopia Digestiva
city: Roma
country: Italy
facility: UOC Medicina Interna a Gastroenterologia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: A.S.O. Ordine Mauriziano Di Torino S.C.
city: Ageo-shi
country: Japan
facility: Ohmori Toshihide gastro-intestinal Clinic
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Chuo-ku
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
city: Fukuoka-shi
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hiroshima-shi
country: Japan
facility: Hiroshima Prefectural Hospital
city: Jonan-ku
country: Japan
facility: Fukuoka University Hospital
city: Kawagoe
country: Japan
facility: Saitama Medical Center, Saitama Medical University
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
city: Kyoto-shi
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nishi-ku
country: Japan
facility: Saiseikai Niigata Daini Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine College Hospital
city: Oita-shi
country: Japan
facility: Ishida IBD Clinic
city: Okayama-city
country: Japan
facility: Okayama University Hospital
city: Osaka-City
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Wakakusa-Daiichi Hospital
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Tokito Clinic
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Suita
country: Japan
facility: Osaka University Hospital
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Toyota-shi
country: Japan
facility: Ieda Hospital
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama-shi
country: Japan
facility: Yokohama Health Medicine Association Kannai Suzuki Clinic
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Guri-Si
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Center
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Alkmaar
country: Netherlands
facility: NZW Alkmaar (Noordwest Ziekenhuisgroep)
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Southern District Health Board - Dunedin Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Tauranga
country: New Zealand
facility: Bay of Plenty District Health Board - Tauranga Hospital
city: Wellington
country: New Zealand
facility: Hutt Valley District Health Board - Hutt Valley Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
city: Bydgoszcz
country: Poland
facility: VITAMED Galaj i Cichomski spólka jawna
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
city: Bydgoszcz
country: Poland
facility: Gabinet Lekarski Janusz Rudzinski
city: Czestochowa
country: Poland
facility: NZOZ INTER-MED, Centrum Endoskopowe
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o
city: Lodz
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego
city: Piotrków Trybunalski
country: Poland
facility: Trialmed Crs
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z o.o. Medic-R Sp.k.
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
city: Tychy
country: Poland
facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
city: Warszawa
country: Poland
facility: Bodyclinic
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.
city: Covilhã
country: Portugal
facility: Centro Hospitalar Cova de Beira, EPE
city: Faro
country: Portugal
facility: Centro Hospitalar do Algarve EPE
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho
city: Bucharest
country: Romania
facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
city: Bucuresti
country: Romania
facility: MedLife, Gastroenterologie
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
city: Bucuresti
country: Romania
facility: Delta Health Care/ Ponderas Academic Hospital
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
city: Bucuresti
country: Romania
facility: MedLife, Gastroenterologie
city: Iasi
country: Romania
facility: Gastromedica SRL, Gastroenterologie
city: Timisoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
city: Timisoara
country: Romania
facility: Centrul Medical Tuculanu, Gastroenterologie
city: Timisoara
country: Romania
facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
city: Irkutsk
country: Russian Federation
facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
city: Saint-Petersburg
country: Russian Federation
facility: "Scientific Research Centre ECO-safety" LLC
city: Saint-Petersburg
country: Russian Federation
facility: "PolyClinic EXPERT" LLC
city: Saratov
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Hospital"
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bratislava
country: Slovakia
facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov
city: Nitra
country: Slovakia
facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
city: Presov
country: Slovakia
facility: Gastro I., s.r.o.
city: Cape Town
country: South Africa
facility: Dr MJ Prins
city: Cape Town
country: South Africa
facility: Dr John P Wright
city: Johannesburg
country: South Africa
facility: Peermed Clinical Trial Centre
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria "Dr. Negrin"
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pontevedra
country: Spain
facility: Hospital de Montecelo
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Usansolo
country: Spain
facility: Hospital de Galdakao-Usandolo
city: Colombo
country: Sri Lanka
facility: National Hospital of Sri Lanka
city: Galle
country: Sri Lanka
facility: Karapitiya Teaching Hospital
city: Kandy
country: Sri Lanka
facility: Kandy Teaching Hospital
city: Ragama
country: Sri Lanka
facility: Colombo North Teaching Hospital
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus AB
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Bern
country: Switzerland
facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Chang Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital, Taipei
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
city: Chernivtsi
country: Ukraine
facility: Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
city: Dnipropetrovsk
country: Ukraine
facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
city: Ivano-Frankivsk
country: Ukraine
facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
city: Kropyvnytskyi
country: Ukraine
facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital No. 18, Proctology Department
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
city: Odessa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
city: Ternopil
country: Ukraine
facility: Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology
city: Uzhgorod
country: Ukraine
facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
city: Vinnytsia
country: Ukraine
facility: Medical Center LLC "Health Clinic"
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Foundation Trust
state: Norfolk
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bury
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: High Wycombe
country: United Kingdom
facility: Wycombe Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, St Mary's Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Prescot
country: United Kingdom
facility: St Helens and Knowsley Teaching Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References: