Clinical trial NCT03279081: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
Official title: A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
complex perianal fistula(s)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (\>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Detailed description: This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease.

The study will randomize approximately 554 participants.

* Cx601 eASCs intralesional injection
* Placebo - Cx601 placebo-matching eASCs intralesional injection

Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS). The study will follow an add-on design, participants receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the CD will be allowed to continue it throughout the study.

The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both participant and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy.

This multicenter trial will be conducted globally across 150 centers. The overall time to participate in this study is approximately 5 years.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Participants of either gender greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years of age.
3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment; a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria :

   * High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
   * Presence of \>=2 external openings.
   * Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible.
5. Clinically controlled, nonactive or mildly active CD, during the last six months prior to Screening visit with:

   * A patient reported outcomes (PRO-2) score \<14 at Screening, AND
   * A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic mucosa:

     - If colonoscopy data are not available within 6 months prior to Screening:
   * A simple endoscopic score for Crohn's Disease (SES-CD) \<=6 with absence of rectal ulcers larger than 0.5 cm must be documented in a colonoscopy performed at Screening before randomization.

     - If colonoscopy data are available within 6 months prior to Screening, the following must be documented, otherwise a new colonoscopy (as above) will be mandatory:
   * The absence of ulcers larger than 0.5 cm in the colonic mucosa AND
   * the improvement or no worsening in abdominal pain and/or in the diarrhea, sustained for one week or more, since the last colonoscopy was performed in the clinical records until Screening visit.

   AND

   o No hemoglobin decrease \>=2.0 gram per deciliter (g/dL) or an unexplained rising C-reactive protein (CRP), \> 5.0 milligram per liter (mg/L) to a concentration above the referenced upper limit of normal (ULN) (unless the rise is due to a known process other than luminal Crohn's Disease), since the last colonoscopy was performed as compared to results during the Screening visit.

   AND

   o no initiation or intensification of treatment with corticosteroids, immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last endoscopy up to Screening visit.
6. Participants whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or vedolizumab or ustekinumab, or having documented intolerance to any of these treatments administered at least at approved or recommended doses during the minimum period mentioned:

   * Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day \[mg/kg/day\]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
   * TNFalpha antagonists:
   * Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8 weeks, or more frequently.
   * Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study. For induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks after. For maintenance: 40 mg subcutaneously every other week, or weekly.
   * Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
   * Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8 weeks.
   * Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study. For induction: Ustekinumab, approximately 6mg/kg intravenously initially then followed by 90 mg subcutaneously every 8 weeks.
7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 international units \[IU\] human chorionic gonadotropin \[hCG\]). Both WCBP or male participants participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study. An adequate method of contraception is defined as complete, non-periodic sexual abstinence (refraining from heterosexual intercourse), single-barrier method, vasectomy, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).

Exclusion Criteria:

1. Concomitant rectovaginal or rectovesical fistula(s).
2. Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs.
3. Presence of a perianal collection \>2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0).
4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large \>0.5 cm ulcers in the rectum) that make impossible to follow the surgery procedure manual.
5. Participant with diverting stomas.
6. Active, uncontrolled infection requiring parenteral antibiotics.
7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit.
8. Participants with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:

   * Serum creatinine levels \>1.5 times the ULN
   * Total bilirubin \>1.5 ULN
   * Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) \>3 times ULN
   * Hemoglobin \<10.0 g/dL
   * Platelets \<75.0\*10\^9/L
   * Albuminemia \<3.0 g/dL
9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit.
10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Participants with basal-cell carcinoma of the skin completely resected outside the perineal region can be included.
11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in participants increased risk from study participation and/or lack of compliance with study procedures.
12. Participants with primary sclerosing cholangitis.
13. Participants with known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to Screening.
14. Congenital or acquired immunodeficiencies, including participants known to be HIV carriers
15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI contrast).
16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip replacements or severe claustrophobia).
17. Severe trauma within 6 months prior to Screening visit.
18. Pregnant or breastfeeding women.
19. Participants who do not wish to or cannot comply with study procedures.
20. Participants currently receiving, or having received any investigational drug within 3 months prior to Screening visit.
21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study.
22. Any major surgery of the GI tract (including one or more segments of the colon or terminal ileum) within 6 months prior the screening or any minor surgery of the GI tract within 3 months prior to screening.
23. Participants who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study.
24. Contraindication to the anaesthetic procedure.

Primary outcomes:
measure: Percentage of Participants With Combined Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission at Week 24
timeFrame: Week 24
measure: Time to Clinical Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Combined Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Clinical Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Clinical Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Clinical Response at Week 52
timeFrame: Week 52
measure: Time to Clinical Remission at Week 52
timeFrame: Week 52
measure: Time to Clinical Response at Week 24
timeFrame: Week 24
measure: Time to Clinical Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Relapse by Week 52 After Achieving Combined Remission at Week 24
timeFrame: From Week 24 to Week 52
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
timeFrame: From first dose of study drug to end of follow up period (up to Week 52)
measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters
timeFrame: From first dose of study drug to end of follow up period (up to Week 52)
measure: Number of Participants With Clinically Significant Changes in Laboratory Parameters
timeFrame: From first dose of study drug to end of follow up period (up to Week 52)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Mayo Clinic
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Health Systems
state: California
city: Los Angeles
country: United States
facility: University of Southern California (USC) Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center - Chao Family Comprehensive Cancer
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Francisco
country: United States
facility: Kaiser Permamente
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Vallejo
country: United States
facility: Vallejo Hospital and Medical Offices
state: California
city: West Hollywood
country: United States
facility: Cedar-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Farmington
country: United States
facility: Hartford Hospital - Gastroenterology
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic - Gastroenterology
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine - Colon & Rectal Surgery
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University - Colon and Rectal
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Sxchool of Medicine
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Digestive Health Center of Louisiana
state: Louisiana
city: Metairie
country: United States
facility: Colon and Rectal Surgery Associates
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medicine - The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts - colon & rectal surgery
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital - Gastroenterology
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center - Cancer Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center - Gastroenterology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital - Gastroenterology
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Stony Brook University Medical Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: OHSU Digestive Health Center
state: Oregon
city: Hershey
country: United States
facility: Harvard Medical School-Beth Israel Deaconess Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center - Surgery
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Providence
country: United States
facility: University Surgical Associates-Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Gastroenterology - Gastroenterology
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (BCM) - Gastroenterology
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center - Gastroenterology
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology
state: Wisconsin
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
state: Vlaams Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan - Gastro-enterology
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta vzw - Maag-darm-leverziekten
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology
city: Antwerpen
country: Belgium
facility: Imelda Ziekenhuis
city: Gent
country: Belgium
facility: UZ Gent - Gastroenterology
city: Liege
country: Belgium
facility: CHU de Liege - Domaine Universitaire du Sart Tilman
city: Liege
country: Belgium
facility: Clinique Saint-Joseph (CHC)
city: Namur
country: Belgium
facility: CHU Dinant Godinne UCL Namur
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Toronto - Gastroenterology
state: Ontario
city: Toronto
country: Canada
facility: Kensington Screening Clinic - Gastroenterology
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Montreal General Hospital
state: Quebec
city: Horovice
country: Czechia
facility: NH Hospital a.s.
state: Beroun
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
city: Kobenhavn
country: Denmark
facility: Bispebjerg Hospital
state: Copenhague
city: Aarhus
country: Denmark
facility: Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Nice Cedex 03
country: France
facility: CHU de Nice
state: Alpes-Maritimes
city: Clermont-Ferrand cedex 1
country: France
facility: CHU de Clermont-Ferrand - Estaing
state: Auvergne
city: Toulouse cedex 09
country: France
facility: Centre Hospitalier Universitaire De Toulouse - Hopital De Ra
state: Haute-Garonne
city: Clichy
country: France
facility: Hopital Beaujon
state: Ile-de-France
city: Paris
country: France
facility: Hopital Saint Louis - Gastro-hepatoenterologie
state: Ile-de-France
city: Rennes
country: France
facility: CHRU Hopital De Pontchaillou
state: Ille-et-Vilaine
city: St Priest en Jarez
country: France
facility: CHU Saint Etienne
state: Loire
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie
state: Lorraine
city: Lille
country: France
facility: CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie
state: Nord
city: AMIENS cedex 1
country: France
facility: CHU Amiens-Picardie
state: Picardie
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone
city: Paris
country: France
facility: Paris St. Joseph Hospital
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
state: Bayern
city: Munchen
country: Germany
facility: Klinikum der Universitat Munchen - Campus Grosshadern
state: Bayern
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitat
state: Hessen
city: Dresden
country: Germany
facility: Universitatsklinikum Dresden
state: Sachsen
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
state: Pest
city: Petah Tikva
country: Israel
facility: Rabin Med Ctr Beilinson Hosp
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Medical Centre
state: HaZafon
city: Tel Hashomer
country: Israel
facility: Chaim sheba Medical Center
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center - Gastroenterology
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-
state: Yerushalayim
city: Cento
country: Italy
facility: Ospedale Santissima Annunziata
state: Ferrara
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center
state: Milano
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.
city: Modena
country: Italy
facility: AOU Policlinico di Modena - Gastroenterologia
city: Napoli
country: Italy
facility: II Universita degli Studi di Napoli
city: Palermo
country: Italy
facility: Gastroenterology Section
city: Pisa
country: Italy
facility: Universita degli studi di Pisa
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Roma
country: Italy
facility: Complesso Integrato Columbus
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
state: Lodzkie
city: Krakow
country: Poland
facility: Centrum Medyczne PROMED
state: Malopolskie
city: Warszawa
country: Poland
facility: Wielospecjalistyczny Szpital Medicover
state: Mazowieckie
city: Sopot
country: Poland
facility: Endoskopia Sp z o.o.
state: Pomorskie
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico School of Medicine
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: Badalona
country: Spain
facility: H.U. G.Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: C.H.U. de Pontevedra
city: Sevilla
country: Spain
facility: H.U.V. del Rocio
city: Linkoping
country: Sweden
facility: Linkoping University Hospital - Department of Surgery
state: Ostergotlands Lan [se-05]
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)
state: Glasgow City
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital
state: London, City Of
city: London
country: United Kingdom
facility: Guys & St Thomas
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Surgery
state: Nottinghamshire
city: London
country: United Kingdom
facility: University Colleague London Hospital (UCLH)
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital - Gastroenterology
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: