Clinical trial NCT03627091: Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
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 efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).


Eligibility criteria: Inclusion Criteria:

* Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
* Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.
* Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:

  1. Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to \>=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or
  2. Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
* Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days\* and average daily stool type frequency \<=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days\*.
* A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.
* A decrease of \>=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days\*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days\*.
* A decrease of \>=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days\*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days\*.

  \*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
* Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

* Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
* Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
* Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
* Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.
* Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
* Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
* Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
* Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
* Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example \[eg,\] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic \[eg, Felty's syndrome\], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
* Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
* Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.

  1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels \>= 3.0 × the upper limit of normal (ULN).
  2. Total bilirubin level \>=1.5 × ULN or \>2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
  3. Hemoglobin level \<=80 gram per liter (g/L) (8.0 gram per deciliter \[g/dL\]).
  4. Platelet count \<=100 × 10\^9/L (100,000 cells per cubic millimeter \[mm\^3\]) or \>=1000 × 10\^9/L (1,000,000 cells/mm\^3).
  5. White blood cell count \<=3.5 × 10\^9/L (3500 cells/mm\^3).
  6. Absolute neutrophil count\<2 × 10\^9/L (\<2000 cells/mm\^3)
  7. Serum creatinine level \>1.5 × ULN or estimated glomerular filtration rate \<30 milliliter per minute (mL/min)/1.73 m\^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

     * Note: If platelet count is \<150,000 cells/mm\^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
* Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
* Participants who are participating in other investigational studies (other than induction studies SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]) or plan to participate in other investigational studies during this study.

Primary outcomes:
measure: Number of Participants With Clinical Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Enhanced Endoscopic Response at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52
timeFrame: At Week 52
measure: Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52
timeFrame: At Week 52
measure: Number of Participants With Sustained Clinical Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
timeFrame: At Week 52
measure: Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52
timeFrame: At Week 52
measure: Number of Participants With Complete Endoscopic Healing at Week 52
timeFrame: At Week 52
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Digestive Health Mesa - East
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies - Phoenix - Clinedge - PPDS
state: Arizona
city: Tucson
country: United States
facility: CATS Research Center - University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research - Clinedge - PPDS
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Lancaster
country: United States
facility: OM Research LLC - Lancaster - ClinEdge - PPDS
state: California
city: Poway
country: United States
facility: Alliance Clinical Research-(Vestavia Hills)
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Pablo
country: United States
facility: Care Access Research, San Pablo
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates PC - CRN - PPDS
state: Colorado
city: Cape Coral
country: United States
facility: Renaissance Research Medical Group, INC
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Coral Gables
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Coral Springs
country: United States
facility: Alliance Medical Research LLC
state: Florida
city: Kissimmee
country: United States
facility: SIH Research
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Hi Tech and Global Research, LLc
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Pharma Research International Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants LLC - Clinedge - PPDS
state: Florida
city: Pinellas Park
country: United States
facility: Accel Research Sites - St. Petersburg - ERN - PPDS
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Tampa
country: United States
facility: Bayside Clinical Research - New Port Richey
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Atlanta
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology PC
state: Georgia
city: Chicago
country: United States
facility: Loretto Hospital
state: Illinois
city: Gurnee
country: United States
facility: IL Gastroenterology Group
state: Illinois
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Houma
country: United States
facility: CroNOLA, LLC.
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - ClinEdge - PPDS
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center LLC
state: Louisiana
city: Brockton
country: United States
facility: Commonwealth Clinical Studies LLC
state: Massachusetts
city: Winchester
country: United States
facility: Winchester Gastroenterology Associates
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC
state: Michigan
city: Duluth
country: United States
facility: Mayo Clinic Health System - PPDS
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Gastroenterology PA
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: North Las Vegas
country: United States
facility: Encompass Care
state: Nevada
city: Brooklyn
country: United States
facility: New York Total Medical Care PC
state: New York
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Orchard Park
country: United States
facility: Southtowns Gastroenterology, PLLC
state: New York
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Fairfield
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: State College
country: United States
facility: Penn State Hershey Medical Group
state: Pennsylvania
city: Wyomissing
country: United States
facility: Digestive Disease Associates
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology-Union City
state: Tennessee
city: Cypress
country: United States
facility: Northside Gastroenterology
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Precision Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute LLC
state: Texas
city: Webster
country: United States
facility: Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research
state: Utah
city: Galax
country: United States
facility: Mid Atlantic Health Specialists
state: Virginia
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Klinikum Graz
state: Steiermark
city: Vienna
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Wien
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Wien
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Bonheiden
country: Belgium
facility: Academisch Medisch Centrum Amsterdam
state: Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Mouscron
country: Belgium
facility: CHU Mouscron
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Center Banja Luka
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
state: Sofia-Grad
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Eurohospital
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment Sofia
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
city: Sofia
country: Bulgaria
facility: Medical Center Convex EOOD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre Mladost - M OOD
city: Cali
country: Colombia
facility: Fundación Valle Del Lili
state: Valle Del Cauca
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: Grad Zagreb
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Virovitica
country: Croatia
facility: General Hospital Virovitica
city: Parnu
country: Estonia
facility: OÜ LV Venter
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Munich
country: Germany
facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen
state: Bayern
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Gastro Campus Research GbR
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitatsklinikum Jena
state: Thüringen
city: Berlin-Zehlendorf
country: Germany
facility: Gastroenterologische Facharztpraxis am Mexikoplatz
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Biberach an der Riss
country: Germany
facility: Sana Klinikum Biberach
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Paliao Faliro
country: Greece
facility: Iatriko Palaiou Falirou
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Euromedica - PPDS
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: ENDOMEDIX Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa János Kórház
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Tiberias
country: Israel
facility: Baruch Padeh Poriya Medical Center
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini Di Catanzaro
state: Calabria
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
state: Lazio
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
city: Roma
country: Italy
facility: La Sapienza-Università di Roma-Policlinico Umberto I
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Kobe-shi
country: Japan
facility: Medical Corporation Aoyama Clinic
state: Hyôgo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine
state: Hyôgo
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Ome
country: Japan
facility: Ome Municipal General Hospital
state: Tokyo
city: Asahikawa
country: Japan
facility: Kunimoto Hospital
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
city: Onomichi
country: Japan
facility: Onomichi General Hospital
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Chiinkai Dojima General & Gastroenterology Clinic
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Otsu-Shi
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokyo
country: Japan
facility: Nihonbashi Egawa Clinic
city: Yokohama
country: Japan
facility: Colo-Proctology Center Matsushima Clinic
city: Oita-city
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
state: Ôita
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gang'weondo
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
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: Inje University Seoul Paik Hospital
city: Beirut
country: Lebanon
facility: Al Zahraa University Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius City Clinical Hospital
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Clinica de Higado y Gastroenterologia Integral, S.C.
state: Morelos
city: Cuernavaca
country: Mexico
facility: JM Research S.C
state: Morelos
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
state: Nuevo León
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
state: Yucatán
city: Distrito Federal
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Tilburg
country: Netherlands
facility: ETZ-Elisabeth
state: Noord-Brabant
city: Den Helder
country: Netherlands
facility: NWZ, location Alkmaar
state: Noord-Holland
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: South Island
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Lexmedica
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski sp.j.
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
state: Kujawsko-pomorskie
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
state: Kujawsko-pomorskie
city: Lódz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
state: Lódzkie
city: Lódz
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
state: Lódzkie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
state: Mazowieckie
city: Warszawa
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
state: Mazowieckie
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny w Warszawie
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Konskie
country: Poland
facility: Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
state: Swietokrzyskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Czestochowa
country: Poland
facility: Centrum Medyczne Czestochowa - PRATIA - PPDS
city: Gdynia
country: Poland
facility: Centrum Medyczne Gdynia - PRATIA - PPDS
city: Katowice
country: Poland
facility: NZOZ All Medicus
city: Lodz
country: Poland
facility: Med Gastr Sp.z.o.o Sp.k
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
city: Rzeszow
country: Poland
facility: Centrum Medyczne Warszawa - PRATIA - PPDS
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia M D M
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Warszawa
country: Poland
facility: BioVirtus Centrum Medyczne
city: Zamosc
country: Poland
facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Portimão
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Bucharest
country: Romania
facility: Sana Monitoring SRL
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cluj-Napoca Emergency Clinical County Hospital
state: Cluj
city: Bucharest
country: Romania
facility: Dr.Carol Davila Emergency University Central Military Hospital
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Prof. Dr. Matei Bals Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Emergency University Hospital
city: Bucuresti
country: Romania
facility: Centrul Medical Hifu Terramed Conformal S.R.L.
city: Constanta
country: Romania
facility: Affidea Romania SRL
city: Iasi
country: Romania
facility: Gastromedica SRL
city: Oradea
country: Romania
facility: Dr. Tirnaveanu Amelita Private Practice
city: Timisoara
country: Romania
facility: Dr. Goldis Gastroenterology Center SRL
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: Samara
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
city: Saratov
country: Russian Federation
facility: SHI Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Elizabeth Municipal Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Vrsac
country: Serbia
facility: General Hospital Vrsac
city: Zemun
country: Serbia
facility: Clinical Hospital Center Zemun
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
state: Šumadijski Okrug
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro LM, s.r.o.
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr. J Breedt
state: Gauteng
city: Claremont
country: South Africa
facility: Dr JP Wright
state: Western Cape
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
state: Madrid, Communidad Delaware
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Centro Medico Teknon - Grupo Quironsalud
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
state: Chernivets'ka Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
state: Kharkivs'ka Oblast
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
state: Kyïv
city: Dnipro
country: Ukraine
facility: LLC Medical Center Family Medicine Clinic
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
city: Kherson
country: Ukraine
facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Medical Center OK!Clinic+LLC International Institute of Clinical Research
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Center Dopomoga-Plus
city: Kyiv
country: Ukraine
facility: Municipal Institution of KRC Kyiv Regional Hospital #2
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
city: Zaporizhzhia
country: Ukraine
facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Northumberland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - PPDS
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital - PPDS
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: