Clinical trial NCT02620046: A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
Official title: A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Crohn's Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC.

Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.

For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.

Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.

After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Detailed description: The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants receiving SC 108 mg Q2W who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria:

1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
timeFrame: Up to 97.9 months
Secondary outcomes:
measure: Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
timeFrame: Up to 97.9 months
measure: Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48
timeFrame: Week 48
measure: Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48
timeFrame: Week 48
measure: Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score
timeFrame: Week 48
measure: Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores
timeFrame: Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Wheat Ridge
country: United States
facility: Rocky Mountain Clinical Research, LLC
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Gastroenterology Associates
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami
country: United States
facility: L & L Research Choices, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Pembroke Pines
country: United States
facility: BRCR Medical Center, Inc.
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLL
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates
state: Kentucky
city: Owensboro
country: United States
facility: Research Concierge, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Lafayette
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Ocean Springs
country: United States
facility: Digestive Health Center PA
state: Mississippi
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc
state: Ohio
city: Lima
country: United States
facility: Gastro-Enterology Research of Lima
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Perkasie
country: United States
facility: Main Line Gastroenterology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Seattle Main Clinic
state: Washington
city: Milwaukee
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Viamonte SRL
state: Ciudad Autonoma Buenos Aires
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Tennyson Centre Day Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Bentleigh East
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Malvern
country: Australia
facility: St Frances Xavier Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Kennedylaan
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Roeselare
country: Belgium
facility: AZ Delta
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Goiania
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
state: Goias
city: Rio de Janeiro
country: Brazil
facility: HUGG - Hospital Universitario Gaffree e Guinle
state: Rio Do Janeiro
city: Rio de Janeiro
country: Brazil
facility: HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
state: Rio Do Janeiro
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericordia de Santos
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: Sao Paulo
city: Pleven
country: Bulgaria
facility: "MHAT Avis - Medica" OOD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Silistra
country: Bulgaria
facility: MHAT - Silistra AD
city: Sliven
country: Bulgaria
facility: MC "Tsaritsa Yoanna' EOOD
city: Sliven
country: Bulgaria
facility: MHAT "Hadzhi Dimitar", OOD
city: Sofia
country: Bulgaria
facility: Second MHAT - Sofia AD
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Excelsior", OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: UMHAT 'Sveta Anna' AD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre - University of Alberta
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Rijeka
country: Croatia
facility: Special Hospital Medico
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: University hospital centre Zagreb
city: Brno
country: Czechia
facility: CCBR - Czech Brno, s.r.o..
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o.
city: Plzen
country: Czechia
facility: A-SHINE s.r.o.
city: Praha 10
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha 3
country: Czechia
facility: CCBR Czech Prague, s.r.o.
city: Praha 5
country: Czechia
facility: Axon Clinical s.r.o.
city: Tabor
country: Czechia
facility: Nemocnice Tabor a.s.
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Muenchen
country: Germany
facility: LMU - Campus Grosshadern
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R
state: Sachsen Anhalt
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig Holstein
city: Lubeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Charite - Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz-Rendelointezet
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Milano
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliera Ospedale Cannizzaro
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Nagoya-shi
country: Japan
facility: Yokoyama IBD Clinic
state: Aichi-Ken
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba-Ken
city: Matsuyama-shi
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime-Ken
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka-Ken
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo-Ken
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate-Ken
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa-Ken
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa-Ken
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama-Ken
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka-Fu
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga-Ken
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga-Ken
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu South Hospital
state: Shizuoka-Ken
city: Bunkyo-ku
country: Japan
facility: Medical Hospital, Tokyo Medical and Dental University
state: Tokyo-To
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo-To
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo-To
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo-To
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama-Ken
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyeongsangbuk-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
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: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Klaipeda
country: Lithuania
facility: Klaipeda Republican Hospital, Public Institution
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics, Public Institution
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Leon
country: Mexico
facility: Centro de Investigacion Farmacologica del Bajio, S.C.
state: Guanajuato
city: Zapopan
country: Mexico
facility: iBiomed Guadalajara
state: Jalisco
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Christus Muguerza Sur S.A. de C.V.
state: Nuevo Leon
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bialystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Katowice
country: Poland
facility: SP CSK im. prof. K. Gibinskiego SUM
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
city: Lodz
country: Poland
facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Lublin
country: Poland
facility: GASTROMED Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Wroclaw
country: Poland
facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Krasnoyarsk
country: Russian Federation
facility: TSBIH "Territorial Clinical Hospital"
city: Moscow
country: Russian Federation
facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
city: Novosibirsk
country: Russian Federation
facility: LLC "Novosibirsk GastroCenter"
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Rostov-on-Don
country: Russian Federation
facility: SBEI HPE "Rostov State Medical University" of the MoH of the RF
city: Saint-Petersburg
country: Russian Federation
facility: LLC "RIAT SPb"
city: Sestroretsk
country: Russian Federation
facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"
city: St. Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Helth Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
city: Kosice
country: Slovakia
facility: Gastroped s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro I, s.r.o.
city: Pretoria
country: South Africa
facility: Dr CCM Ziady Practice
state: Gauteng
city: Cape Town
country: South Africa
facility: Dr MJ Prins Practice
state: Western Cape
city: Cape Town
country: South Africa
facility: Dr JP Wright Practice
state: Western Cape
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset - Solna
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: RCNECRCH Dept of Surgery, SHEI Ukr BSMU
city: Dnipro
country: Ukraine
facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
city: Ivano-Frankivsk
country: Ukraine
facility: Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
city: Kherson
country: Ukraine
facility: CI A.and O. Tropiny City Clinical Hospital
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
city: Kyiv
country: Ukraine
facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Odesa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
state: Devon
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Greater London
city: London
country: United Kingdom
facility: Royal Free Hospital
state: Greater London
city: London
country: United Kingdom
facility: St George's Hospital
state: Greater London
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: Shropshire
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: West Midlands
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton hospital
state: West Midlands
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: