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NCT06254950Active, not recruitingPhase 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 Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
213 (actual)
First submitted
2 Feb 2024
Start date
29 Mar 2024
Primary completion date
14 Jul 2026
Lead sponsor
Takeda
NCT number
NCT06254950
EU CT number
2023-506769-67-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 213
  • From 29 Mar 2024 to the primary completion date, 14 Jul 2026
  • 141 sites in 22 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

  • Participants who have failed 3 or more classes of advanced therapies.

Other illness

  • Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
  • Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.

Other

  • Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.

Who the study is looking for

  • Male or female aged 18-75 years old with diagnosis of UC 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 UC assessed by mMS and ES.
  • Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
  • Participants must meet the contraception recommendations.

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

Full criteria on ClinicalTrials.gov

Sites (141)

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 ParkAustraliaUnknown status
The Alfred Hospital
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MelbourneAustraliaUnknown status
Western Health - Footscray Hospital
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MelbourneAustraliaUnknown status
Harry Perkins Medical Research Institute Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Sir Charles Gairdner Hospital Lung Institute Of Western Australia
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NedlandsAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
Mater Cancer Care Centre-Mater Health Services
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South BrisbaneAustraliaUnknown status
Concord Repatriation General Hospital
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SydneyAustraliaUnknown status
The Queen Elizabeth Hospital
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WoodvilleAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaActive, not recruiting
Acibadem City clinic University Hospital EOOD
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SofiaBulgariaActive, not recruiting
Medical center Asclepion humane medicine researches EOOD
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SofiaBulgariaActive, not recruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaActive, not recruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaActive, not recruiting
University Hospital Queen Govanna
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SofiyaBulgariaActive, not recruiting
Heritage Medical Research Clinic - University Of Calgary
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CalgaryCanadaUnknown status
London Health Sciences Centre, University Hospital
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LondonCanadaUnknown status
London Health Sciences Centre · Victoria Hospital
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LondonCanadaUnknown status
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaUnknown status
The Research Institute of the McGill University Health Center
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MontrealCanadaUnknown status
Fraser Clinical Trials
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New WestminsterCanadaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The Second People's Hospital of Changzhou
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ChangzhouChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
Wuhan University - Renmin Hospital (Hubei General Hospital)
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ChongqingChinaUnknown status
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
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GuangzhouChinaUnknown status
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
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HangzhouChinaUnknown status
Shanghai Pudong New District Zhoupu Hospital
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ShanghaiChinaUnknown status
Renji Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
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ShenyangChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
SurGal Clinic s.r.o.
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Brno-SeverCzechiaActive, not recruiting
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaActive, not recruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Gastromedic s.r.o
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PardubiceCzechiaActive, not recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaActive, not recruiting
Endohope klinika s.r.o.
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PragueCzechiaActive, not recruiting
Axon Clinical s.r.o.
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Prague 5CzechiaActive, not recruiting
EndoArt s.r.o.
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Slezska OstravaCzechiaActive, not recruiting
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaActive, not recruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyActive, not recruiting
Praxis für Gastroenterolgie
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyActive, not recruiting
St. Marien und St. Annastiftskrankenhaus
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Ludwigshafen am RheinGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkActive, not recruiting
Aalborg University Hospital
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GistrupDenmarkActive, not recruiting
Hillerod Hospital
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HilleroedDenmarkActive, not recruiting
Hvidovre Hospital
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HvidovreDenmarkActive, not recruiting
Region Sjaelland
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KoegeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceActive, not recruiting
CHRU De Nancy
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Nancy CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-EtienneFranceActive, not recruiting
South Eastern Health and Social Care Trust - The Ulster Hospital
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BelfastUnited KingdomUnknown status
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
Clinical Research Centre - Barts Health NHS Trust
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LondonUnited KingdomUnknown status
General Hospital of Athens "G. Gennimatas"
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AthensGreeceCompleted
Evaggelismos Hospital
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AthensGreeceCompleted
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Semmelweis University
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BudapestHungaryActive, not recruiting
Clinexpert Kft.
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Budapest IIIHungaryActive, not recruiting
Pannonia Maganorvosi Centrum Kft.
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Budapest XIIIHungaryActive, not recruiting
EURO-ENDO-MED Kft.
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MohácsHungaryActive, not recruiting
Javorszky Oedoen Korhaz
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VacHungaryActive, not recruiting
Assuta Ashdod University Hospital
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AshdodIsraelUnknown status
Soroka Mc
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BeershebaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
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Ramat GanIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyActive, not recruiting
San Camillo Forlanini Hospital
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Fukuoka University Hospital
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FukuokaJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
The Jikei University Hospital
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MinatoJapanUnknown status
Kitasato University Kitasato Institute Hospital
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Minato-kuJapanUnknown status
Kyorin University Hospital
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MitakaJapanUnknown status
Saga University Hospital
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SagaJapanUnknown status
Toho University Sakura Medical Center
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SakuraJapanUnknown status
Sapporo Medical University Hospital
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SapporoJapanUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center (AMC)
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SeoulSouth KoreaUnknown status
Yonsei University Wonju Severance Christian Hospital
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WŏnjuSouth KoreaUnknown status
Akershus University Hospital
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LoerenskogNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Manermed Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Pratia S.A.
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GdyniaPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandActive, not recruiting
Medrise Sp. z o.o.
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LublinPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandActive, not recruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandActive, not recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandActive, not recruiting
GASTROMED Sp. z o.o.
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TorunPolandActive, not recruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
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TychyPolandActive, not recruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandActive, not recruiting
Medical Network Sp z o o
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WarsawPolandActive, not recruiting
PlanetMed Sp. z o.o.
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WroclawPolandActive, not recruiting
Melita Medical Sp. z o.o.
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WrocławPolandActive, not recruiting
Monza-Ares S.R.L.
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaActive, not recruiting
Delta Health Care S.R.L
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BucharestRomaniaActive, not recruiting
Baneasa Tumor Center Hospital
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BucurestiRomaniaActive, not recruiting
Cabinet Particular Policlinic Algomed S.R.L.
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TimisoaraRomaniaActive, not recruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaActive, not recruiting
Cliniq s.r.o.
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BratislavaSlovakiaActive, not recruiting
ENDOMED, s.r.o.
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KošiceSlovakiaActive, not recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaActive, not recruiting
Accout Center s.r.o.
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ŠahySlovakiaActive, not recruiting
Changhua Christian Hospital (CCH)
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ChanghuaTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital NTUH
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TaipeiTaiwanUnknown status
Emory University Hospital, The Emory Clinic
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AtlantaUnited StatesUnknown status
Novel Research LLC
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BellaireUnited StatesUnknown status
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
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ClearwaterUnited StatesUnknown status
Atlanta Center For Gastroenterology, P.C.
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DecaturUnited StatesUnknown status
Woodholme Gastroenterology Associates
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Glen BurnieUnited StatesUnknown status
Gastroenterology Associates, PA
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GreenvilleUnited StatesUnknown status
Auzmer Research
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LakelandUnited StatesUnknown status
Las Vegas Medical Research
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Las VegasUnited StatesUnknown status
GastroIntestinal BioSciences
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Los AngelesUnited StatesUnknown status
University of Louisville
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LouisvilleUnited StatesUnknown status
United Medical Doctors
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MurrietaUnited StatesUnknown status
GI PROS, Inc.
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NaplesUnited StatesUnknown status
University Gastroenterology
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ProvidenceUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
USF Health Morsani Center for Advanced Healthcare
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TampaUnited StatesUnknown status
Tyler Research Institute, LLC
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TylerUnited StatesUnknown status

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