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NCT06589986Active, not recruitingPhase 3

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
6 Sept 2024
Start date
17 Sept 2024
Primary completion date
30 Jan 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06589986
EU CT number
2024-513014-35-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 17 Sept 2024 to the primary completion date, 30 Jan 2027
  • 207 sites in 31 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

  • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Other illness

  • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
  • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB

Other

  • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed

Who the study is looking for

  • Confirmed diagnosis of UC
  • Moderately to severely active UC assessed by mMS
  • Bodyweight \>= 40 kilogram (kg)
  • Up to date with colorectal cancer (CRC) screening performed according to local standards
  • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
  • Males and females of childbearing potential must meet protocol criteria for contraception requirements

Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (207)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIPREC Centro de Investigacion y Prevencion Cardiovascular
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Expertia S.A- Mautalen Salud e Investigación
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Krankenhaus Der Barmherzigen Brueder Wien
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ViennaAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Lyell McEwin Hospital
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AdelaideAustraliaUnknown status
The Canberra Hospital
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GarranAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Mater Misericordiae Limited
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South BrisbaneAustraliaUnknown status
Royal Prince Alfred Hospital
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SydneyAustraliaUnknown status
Az Maria Middelares Gent
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GentBelgiumActive, not recruiting
CHC MontLégia
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LiègeBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
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Gorna OryahovitsaBulgariaActive, not recruiting
MBAL Sveta Karidad EAD
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PlovdivBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaActive, not recruiting
Meditsinski Tsentar Arkus Medikal A.D.
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Veliko TarnovoBulgariaActive, not recruiting
Hospital de Clínicas de Porto Alegre X
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Porto AlegreBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
BR Trials - Pesquisa Clínica
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São PauloBrazilUnknown status
South Edmonton Gastroenterology
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EdmontonCanadaUnknown status
Hospital Guillermo Grant Benavente
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ConcepciónChileUnknown status
Clínica Universidad de Los Andes
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SantiagoChileUnknown status
Medwal
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SantiagoChileUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Binzhou Medical University Hospital
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BinzhouChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Sichuan Provincial People's Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaUnknown status
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Huizhou First Hospital
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HuizhouChinaUnknown status
Jinhua Municipal Central Hospital
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JinhuaChinaUnknown status
The 1st Affiliated Hospital of Nanchang Unversity
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NanchangChinaUnknown status
Nanjing 1st Hospital
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NanjingChinaUnknown status
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
Hebei Medical University - The Second Hospital
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ShijiazhuangChinaUnknown status
Ren Min Hospital Affiliated Wu Han University
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WuhanChinaUnknown status
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiao Tong University
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Xi'anChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Zhuzhou Central Hospital
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ZhuzhouChinaUnknown status
SurGal Clinic s.r.o.
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Brno-SeverCzechiaActive, not recruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaActive, not recruiting
Gastroenterologie s.r.o.
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Hradec KrálovéCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Region Hovedstaden
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HerlevDenmarkCompleted
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centre Hospitalier Departemental Vendee
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La Roche Sur Yon Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
Royal Liverpool University Hospital
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LiverpoolUnited KingdomUnknown status
Guy's Hospital
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LondonUnited KingdomUnknown status
Poliklinika Borzan d.o.o.
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OsijekCroatiaActive, not recruiting
Clinexpert Kft.
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Budapest IIIHungaryActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
Pannonia Maganorvosi Centrum Kft.
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Budapest XIIIHungaryActive, not recruiting
Clinexpert Gyoengyoes Kft.
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GyongyosHungaryActive, not recruiting
Clinfan Kft.
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SzekszardHungaryActive, not recruiting
Javorszky Oedoen Korhaz
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VacHungaryActive, not recruiting
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
SR Kalla Memorial Gastro & General Hospital
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JaipurIndiaUnknown status
Gujarat Gastro and Vascular Hospital
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SuratIndiaUnknown status
Surat Institute of Digestive Sciences Hospitals
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SuratIndiaUnknown status
Azienda Sanitaria Locale Matera
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MateraItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Cagliari
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MonserratoItalyActive, not recruiting
Università degli studi di Napoli Federico II
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NaplesItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Rhodense
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RhoItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Tsujinaka Hospital Kashiwanoha
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ChibaJapanUnknown status
Hidaka Coloproctology Clinic
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FukuokaJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Japanese Red Cross Takayama Hospital
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GifuJapanUnknown status
Aoyama Clinic;GI Endoscopy & IBD Center
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HyōgoJapanUnknown status
Kagawa Prefectural Central Hospital
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KagawaJapanUnknown status
Sameshima Hospital
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KagoshimaJapanUnknown status
Gokeikai Ofuna Chuo Hospital
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KanagawaJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
Ishida Clinic of IBD and Gastroenterology
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ŌitaJapanUnknown status
National Hospital Organization Osaka National Hospital
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OsakaJapanUnknown status
Saga-ken Medical Centre Koseikan
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SagaJapanUnknown status
Saga University Hospital
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SagaJapanUnknown status
National Hospital Organization Shizuoka Medical Center
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ShizuokaJapanUnknown status
Matsuda Hospital
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ShizuokaJapanUnknown status
JCHO Tokyo Yamate Medical Center
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TokyoJapanUnknown status
Kitasato University Kitasato Institute Hospital
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TokyoJapanUnknown status
Tokai University Hachioji Hospital
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TokyoJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Boca Clinical Trials Mexico S.C. (Guadalajara)
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GuadalajaraMexicoUnknown status
Accelerium, S. de R.L. de C.V.
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MonterreyMexicoUnknown status
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Manermed Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Centrum Medyczne LukaMed Joanna Łuka
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ChojnicePolandActive, not recruiting
Endo-Med Sp. z o.o.
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KarczewPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
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LecznaPolandActive, not recruiting
Umed Clinical Trials Sp. z o.o.
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LodzPolandActive, not recruiting
Allmedica Badania Kliniczne Sp z o.o. Sp K.
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Nowy TargPolandActive, not recruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandActive, not recruiting
Eskulap Pabianice Sp. z o.o.
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PabianicePolandActive, not recruiting
Trialmed Sp. z o. o.
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Piotrkow TrybunalskiPolandActive, not recruiting
Solumed Sp. z o.o. sp.k.
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PoznanPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
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RzeszowPolandActive, not recruiting
Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
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SosnowiecPolandActive, not recruiting
GASTROMED Sp. z o.o.
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TorunPolandActive, 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
Vistamed & Vertigo Sp Z O O
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WroclawPolandActive, not recruiting
Melita Medical Sp. z o.o.
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WroclawPolandActive, not recruiting
EMC Instytut Medyczny S.A.
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WroclawPolandActive, not recruiting
Etg Zamosc Sp. z o.o.
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ZamośćPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local de Saude do Algarve E.P.E.
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FaroPortugalActive, not recruiting
Hospital da Luz, S.A
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LisbonPortugalActive, not recruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
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Santa Maria Da FeiraPortugalActive, not recruiting
Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.
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ViseuPortugalActive, not recruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaCompleted
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaCompleted
Oncomed S.R.L.
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TimisoaraRomaniaCompleted
University Hospital Medical Center Zvezdara
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BelgradeSerbiaUnknown status
University Hospital Medical Center Bezanijska Kosa
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BelgradeSerbiaUnknown status
University Hospital Center Dr Dragisa Misovic - Dedinje
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BelgradeSerbiaUnknown status
Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Clinical Center of Vojvodina
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Novi SadSerbiaUnknown status
Cliniq s.r.o.
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BratislavaSlovakiaActive, not recruiting
Nemocnica BORY a.s.
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BratislavaSlovakiaActive, not recruiting
Nemocnica AGEL Kosice Saca a.s.
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KosiceSlovakiaActive, not recruiting
ENDOMED, s.r.o.
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KošiceSlovakiaActive, not recruiting
Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica
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RužomberokSlovakiaActive, not recruiting
Abawi spol. s r.o.
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VrakunaSlovakiaActive, not recruiting
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
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BangkokThailandUnknown status
Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
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BangkokThailandUnknown status
Liver Research Unit, Srinagarind Hospital
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Khon KaenThailandUnknown status
Thammasat University Hospital
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Pathum ThaniThailandUnknown status
Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
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SongkhlaThailandUnknown status
Surin Hospital
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SurinThailandUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Digestive Health Partners, PA
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AshevilleUnited StatesUnknown status
Boston University
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BostonUnited StatesUnknown status
Brigham & Womens Hosp
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BostonUnited StatesUnknown status
Access Research Institute
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BrooksvilleUnited StatesUnknown status
Medical University of South Carolina (MUSC)
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CharlestonUnited StatesUnknown status
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
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ChesapeakeUnited StatesUnknown status
The University Of Chicago
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ChicagoUnited StatesUnknown status
Gastro Florida
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ClearwaterUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesUnknown status
Ohio Gastroenterology Group
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ColumbusUnited StatesUnknown status
Gastro One
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CordovaUnited StatesUnknown status
Tri-State Gastroenterology Associates
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Crestview HillsUnited StatesUnknown status
The University of Texas Southwestern Medical Center at Dallas
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DallasUnited StatesUnknown status
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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DothanUnited StatesUnknown status
Allied Gastrointestinal Associates, PA
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FlowoodUnited StatesUnknown status
Intercity Gastroenterology
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Fresh MeadowsUnited StatesUnknown status
GI Alliance
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GarlandUnited StatesUnknown status
Peters Medical Research (PMR), LLC
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High PointUnited StatesUnknown status
Grand Teton Research Group, PLLC
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Idaho FallsUnited StatesUnknown status
Indiana University Health University Hospital
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IndianapolisUnited StatesUnknown status
Gastrointestinal Associates of Northeast Tennessee
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Johnson CityUnited StatesUnknown status
Clinical Research of Osceola, LLC
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KissimmeeUnited StatesUnknown status
Auzmer Research
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LakelandUnited StatesUnknown status
Florida Research Institute - Lakewood
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Lakewood RchUnited StatesUnknown status
Om Research LLC
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LancasterUnited StatesUnknown status
Gastroenterology Health Partners, PLLC
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LouisvilleUnited StatesUnknown status
Gastroenterology Associates of Central Georgia
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MaconUnited StatesUnknown status
TDDC dba GI Alliance Research
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MansfieldUnited StatesUnknown status
Homestead Associates in Research Inc.
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MiamiUnited StatesUnknown status
Allied Biomedical Research Institute, Inc
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MiamiUnited StatesUnknown status
Miami Beach Clinical Research Center
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Miami BeachUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Gastroenterology Health Partners, PLLC
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New AlbanyUnited StatesUnknown status
Pioneer Clinical Research NY
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New YorkUnited StatesUnknown status
University of California Irvine
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OrangeUnited StatesUnknown status
University Gastroenterology
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ProvidenceUnited StatesUnknown status
Gastroenterology Consultants of SWVA
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RoanokeUnited StatesUnknown status
Carta - Clinical Associates in Research Therapeutics of America, LLC
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San AntonioUnited StatesUnknown status
Southern Star Research Institute, LLC
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San AntonioUnited StatesUnknown status
Louisiana Research Center - GastroIntestinal Associates
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ShreveportUnited StatesUnknown status
Theia Clinical Research Centers, LLC
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TampaUnited StatesUnknown status
University of Texas Health Center at Tyler
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TylerUnited StatesUnknown status
Tyler Research Institute, LLC
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TylerUnited StatesUnknown status
Gastro Intestinal Research Institute of Northern Ohio,
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WestlakeUnited StatesUnknown status
Florida Medical Clinic
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ZephyrhillsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.