Clinical trial NCT02914535: Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Alfasigma S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2016-09-26
Enrollment: 1173
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 ulcerative colitis (UC).


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 Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
* Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
* Females of childbearing potential must have a negative pregnancy test at Day 1
* Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

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 subject 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
* Use of prohibited medications as outlined in the protocol

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

Primary outcomes:
measure: Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
timeFrame: Up to 336 weeks plus 30 days
Secondary outcomes:
measure: Change From Baseline in Components of Mayo Clinic Score (MCS)
timeFrame: Baseline and up to 336 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists Of The Southeast
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
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: Gainesville
country: United States
facility: UF Clinical Research Center
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
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: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
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: 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: Troy
country: United States
facility: Center for Digestive Health Research
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
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: 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: 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: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
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: 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: Baylor College of Medicine - Baylor Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
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 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: Charlottesville
country: United States
facility: University of Virginia Health System
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: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata
city: Quilmes
country: Argentina
facility: Instituto Médico Cer
city: Clayton
country: Australia
facility: Monash Medical Centre
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: Mountain Creek
country: Australia
facility: Coastal Digestive Health
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: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Universitatsklinik Innsbruck
city: Wien
country: Austria
facility: AKH-Medizinische Universitat Wien
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen, campus Sint-Vincentius
city: Brussel
country: Belgium
facility: CUB Hopital Erasme
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
city: Pleven
country: Bulgaria
facility: MHAT Sveti Pantaleymon- Pleven OOD
city: Veliko Tarnovo
country: Bulgaria
facility: "MDHAT Dr. St.Cherkezov" AD
city: Vidin
country: Bulgaria
facility: MHAT "Sveta Petka" AD
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Clinic
state: Alberta
city: Vancouver
country: Canada
facility: The Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc.
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
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 9
country: Czechia
facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
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: 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: 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: 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: Toulouse
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Vandoeuvre Les Nancy
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: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
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: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Koln
country: Germany
facility: Universitaetsklinik Koln
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
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: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
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: Bekescsaba
country: Hungary
facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
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: Ahmedabad
country: India
facility: Kaizen Hospital
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: Hyderabad
country: India
facility: Gleneagles Global Hospitals
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 Medical College & Hospitals
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mangaluru
country: India
facility: Kasturba Medical College (KMC) Hospital
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: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Secunderabad
country: India
facility: Gandhi Hospital
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: Beaumont Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Castellana Grotte
country: Italy
facility: UOC Gastroenterologia II
city: Catanzaro
country: Italy
facility: U.O. Fisiopatologia Digestiva
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
city: Milano
country: Italy
facility: Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
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: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Medical Hospital, Tokyo Medical and Dental University
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi 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
country: Japan
facility: Hiroshima University Hospital
city: Jonan-ku
country: Japan
facility: Fukuoka University Hospital
city: Kamakura
country: Japan
facility: Ofuna Chuo Hospital
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: 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
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: Sagamihara
country: Japan
facility: Kitasato University Hospital,THE KITASATO INSTITUTE
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: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
city: Toyota-shi
country: Japan
facility: Ieda Hospital
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama-shi
country: Japan
facility: Colo-proctology Center Matsushima Clinic
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam 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: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Cuautitlán Izcalli
country: Mexico
facility: PCR-Phylasis Clinicas Research S. de R.L. de C.V.
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Tauranga
country: New Zealand
facility: Bay of Plenty District Health Board - Tauranga 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: 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: Ksawerów
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
city: Lodz
country: Poland
facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia
city: Piaseczno
country: Poland
facility: Centrum Innowacyjnych Terapii Sp. z o.o.
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia 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, Zmudzinski 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: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
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: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE
city: Bucuresti
country: Romania
facility: MedLife, Gastroenterologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
city: Oradea
country: Romania
facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
city: Timisoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
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: Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
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 Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
city: Saint Petersburg
country: Russian Federation
facility: "Riat" LLC
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: Saratov
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
city: Tyumen
country: Russian Federation
facility: Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Nitra
country: Slovakia
facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
city: Cape Town
country: South Africa
facility: Dr MJ Prins
city: Johannesburg
country: South Africa
facility: Peermed Clinical Trial Centre
city: Barcelona
country: Spain
facility: Centro Medico Teknon
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: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Danderyd University Hospital Corp
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold und Partner
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital, Taipei
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
city: Cherkasy
country: Ukraine
facility: Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
city: Chernivtsi
country: Ukraine
facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
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: L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
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: Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
city: Odessa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
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: Bury
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
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: Imperial College Healthcare NHS Trust, St Mary's Hospital
city: Nottingham
country: United Kingdom
facility: Biomedical Research Unit
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: