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NCT06233461RecruitingPhase 2

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
268 (estimated)
First submitted
23 Jan 2024
Start date
5 Mar 2024
Primary completion date
17 Feb 2027
Lead sponsor
Takeda
NCT number
NCT06233461
EU CT number
2023-506704-14-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 268
  • From 5 Mar 2024 to the primary completion date, 17 Feb 2027
  • 206 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have complications of CD that might require surgery during the study.
  • Participants who have failed 3 or more classes of advanced therapies.

Other illness

  • Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.

Other

  • Participants with a current ostomy.

Who the study is looking for

  • Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age.
  • Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
  • Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (206)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
Northern Hospital Epping
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EppingAustraliaRecruiting
Western Health/Footscray Hospital
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FootscrayAustraliaRecruiting
Harry Perkins Medical Research Institute Fiona Stanley Hospital
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MurdochAustraliaRecruiting
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
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NedlandsAustraliaRecruiting
Royal Perth Hospital
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PerthAustraliaRecruiting
Mater Cancer Care Centre-Mater Health Services
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South BrisbaneAustraliaRecruiting
The Queen Elizabeth Hospital
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WoodvilleAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
CHU Saint-Pierre
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BrusselsBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaRecruiting
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
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SlivenBulgariaRecruiting
Acibadem City clinic University Hospital EOOD
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SofiaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
University Hospital Queen Govanna
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SofiyaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
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BotucatuBrazilNot yet recruiting
L2 IP Instituto de Pesquisas Clinicas Ltda
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BrasíliaBrazilRecruiting
UniversidadeEstadualde Campinas - UNICAMP
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CampinasBrazilRecruiting
Centro de Estudos Clnicos do Interior Paulista (CECIP)
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JaúBrazilNot yet recruiting
Galileo Medical Research
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Juiz de ForaBrazilRecruiting
Hospital de Clínicas de Porto Alegre - HCPA
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Porto AlegreBrazilNot yet recruiting
Ribeiralo Preto Medical School, University of Salo Paulo
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Ribeirão PretoBrazilRecruiting
Irmandade da Santa Casa da Misericórdia de Santos
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SantosBrazilRecruiting
Solare Trials
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São PauloBrazilRecruiting
Heritage Medical Research Clinic - University Of Calgary
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CalgaryCanadaRecruiting
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
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HalifaxCanadaRecruiting
London Health Sciences Centre · Victoria Hospital
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LondonCanadaRecruiting
London Digestive Disease Institute
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LondonCanadaRecruiting
London Health Sciences Centre, University Hospital
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LondonCanadaActive, not recruiting
The Research Institute of the McGill University Health Center
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MontrealCanadaRecruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaRecruiting
Fraser Clinical Trials
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New WestminsterCanadaRecruiting
University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
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TorontoCanadaRecruiting
University Hospital Basel
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BaselSwitzerlandRecruiting
Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
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BernSwitzerlandRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
The Second People's Hospital of Changzhou
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ChangzhouChinaRecruiting
Chongqing General Hospital
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ChongqingChinaRecruiting
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
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GuangzhouChinaRecruiting
Sun Yat-sen University (SYSU) - The First Affiliated Hospital
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GuangzhouChinaRecruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
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HangzhouChinaRecruiting
Huizhou First Hospital
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HuizhouChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai Pudong New District Zhoupu Hospital
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ShanghaiChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
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ShenyangChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Wuhan University - Renmin Hospital (Hubei General Hospital)
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WuhanChinaRecruiting
Zhongshan Hospital Xiamen University
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XiamenChinaRecruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University
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ZhejiangChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
SurGal Clinic s.r.o.
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Brno-SeverCzechiaRecruiting
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaRecruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
PreventaMed, s.r.o.
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OlomoucCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Gastromedic s.r.o
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PardubiceCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaRecruiting
Endohope klinika s.r.o.
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PragueCzechiaRecruiting
Axon Clinical s.r.o.
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Prague 5CzechiaRecruiting
EndoArt s.r.o.
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Slezska OstravaCzechiaRecruiting
Krajská zdravotní a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
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Ústí nad LabemCzechiaRecruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
St. Marien und St. Annastiftskrankenhaus
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Ludwigshafen am RheinGermanyRecruiting
Universitaetsklinikum Mannheim GmbH
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MannheimGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkRecruiting
Region Nordjylland
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GistrupDenmarkRecruiting
Hillerod Hospital
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HilleroedDenmarkRecruiting
Hvidovre Hospital
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HvidovreDenmarkRecruiting
Region Sjaelland
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KoegeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
CHRU De Nancy
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Nancy CedexFranceRecruiting
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Hopital Saint Antoine
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Paris Cedex 12FranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
South Eastern Health and Social Care Trust - The Ulster Hospital
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BelfastUnited KingdomRecruiting
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomRecruiting
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomRecruiting
NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
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LondonUnited KingdomRecruiting
Evaggelismos Hospital
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AthensGreeceRecruiting
General Hospital of Athens "G. Gennimatas"
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AthensGreeceRecruiting
Alexandra Hospital
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
General University Hospital Of Patras
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PatrasGreeceRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
Pannonia Maganorvosi Centrum Kft.
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Budapest XIIIHungaryRecruiting
EURO-ENDO-MED Kft.
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MohácsHungaryRecruiting
Assuta Ashdod Medical Center
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AshdodIsraelRecruiting
Soroka Mc
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BeershebaIsraelRecruiting
Digestive Disease Institute, Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
The Chaim Sheba Medical Center
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Ramat GanIsraelRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
San Camillo Forlanini Hospital
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RomeItalyRecruiting
Humanitas Research Hospital
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RozzanoItalyRecruiting
Tsujinaka Hospital Kashiwanoha
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ChibaJapanRecruiting
Fukuoka University Hospital
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FukuokaJapanRecruiting
Hamamatsu University Hospital
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HamamatsuJapanRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
The Jikei University Hospital
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MinatoJapanRecruiting
Kyorin University Hospital
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MitakaJapanRecruiting
Iwate Medical University Uchimaru Medical Center
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MoriokaJapanRecruiting
Hyogo Medical University Hospital
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NishinomiyaJapanRecruiting
Sapporo Medical University Hospital
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SapporoJapanRecruiting
Tohoku University Hospital
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SendaiJapanRecruiting
Osaka Medical and Pharmaceutical University Hospital
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Takatsuki-shiJapanRecruiting
Institute of Science Tokyo Hospital
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TokyoJapanRecruiting
Toyama University Hospital
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ToyamaJapanRecruiting
Kosin University Gospel Hospital
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BusanSouth KoreaRecruiting
Inje University Haeundae Paik Hospital
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BusanSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Asan Medical Center (AMC)
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Yonsei University Wonju Severance Christian Hospital
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WŏnjuSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsRecruiting
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsRecruiting
Vestre Viken HF
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DrammenNorwayRecruiting
Sykehuset Innlandet HF
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GjoevikNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Manermed Sp. z o.o.
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandRecruiting
AmiCare Sp. z o.o. Sp. k.
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LodzPolandRecruiting
Centrum Medyczne Med-Gastr Sp. z o.o.
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
Solumed Centrum Medyczne Sp. z o.o.
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PoznanPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandRecruiting
Endoskopia Sp z o.o.
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SopotPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
GASTROMED Sp. z o.o.
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TorunPolandRecruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
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TychyPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
PlanetMed Sp. z o.o.
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WroclawPolandRecruiting
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandRecruiting
Centrum Medyczne Oporow
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WroclawPolandRecruiting
Melita Medical Sp. z o.o.
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WroclawPolandRecruiting
Pro Life Medica Sp. z o.o.
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ZamośćPolandRecruiting
Korczowski Bartosz, Gabinet Lekarski
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-PolandRecruiting
Monza-Ares S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaRecruiting
Delta Health Care S.R.L
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BucharestRomaniaRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaRecruiting
Valahia Medical S.R.L.
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PloiestiRomaniaRecruiting
Cabinet Particular Policlinic Algomed S.R.L.
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TimisoaraRomaniaRecruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaRecruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
ENDOMED, s.r.o.
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KošiceSlovakiaRecruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaRecruiting
Accout Center s.r.o.
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ŠahySlovakiaRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
National Taiwan University Hospital NTUH
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TaipeiTaiwanRecruiting
Emory University Hospital, The Emory Clinic
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AtlantaUnited StatesRecruiting
Novel Research LLC
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BellaireUnited StatesRecruiting
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
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ClearwaterUnited StatesRecruiting
TDDC - Baylor University Medical Center Gaston Ave
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DallasUnited StatesCompleted
Atlanta Center For Gastroenterology, P.C.
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DecaturUnited StatesRecruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
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Fort WorthUnited StatesCompleted
Woodholme Gastroenterology Associates
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Glen BurnieUnited StatesRecruiting
Gastroenterology Associates, PA
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GreenvilleUnited StatesRecruiting
The University of Iowa Hospitals & Clinics
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Iowa CityUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
One of a Kind Clinical research Center TX LLC
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KingwoodUnited StatesRecruiting
Auzmer Research
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LakelandUnited StatesRecruiting
Las Vegas Medical Research
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Las VegasUnited StatesRecruiting
BVL Clinical Research
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LibertyUnited StatesRecruiting
University of Louisville
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LouisvilleUnited StatesRecruiting
TDDC dba Alliance Research
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MansfieldUnited StatesCompleted
Great Lakes Gastroenterology Research, LLC
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MentorUnited StatesRecruiting
Wellness Clinical Research
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Miami LakesUnited StatesRecruiting
United Medical Doctors
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MurrietaUnited StatesRecruiting
GI PROS, Inc.
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NaplesUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
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New YorkUnited StatesRecruiting
Hightower Clinical - SSM Health
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Oklahoma CityUnited StatesCompleted
UCI Health
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OrangeUnited StatesRecruiting
AdventHealth (Florida Hospital) Medical Group
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OrlandoUnited StatesNot yet recruiting
University Gastroenterology Providence
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ProvidenceUnited StatesRecruiting
Rochester Clinical Research, Inc
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RochesterUnited StatesNot yet recruiting
Southern Star Research Institute, LLC
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San AntonioUnited StatesRecruiting
University of Washington Medical Center
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SeattleUnited StatesRecruiting
USF Health Morsani Center for Advanced Healthcare
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TampaUnited StatesRecruiting
Tyler Research Institute, LLC
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TylerUnited StatesRecruiting

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