A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis (ELASCOPE)
October 20, 2026 updated by: Ipsen
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death.
In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up.
During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety.
Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
350
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ipsen Clinical Study Enquiries
- Phone Number: see email
- Email: clinical.trials@ipsen.com
Study Locations
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Not yet recruiting
- GEDYT (Gastroenterologia Diagnostica y Terapeutica)
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San Juan Bautista, Buenos Aires, Argentina, 1888
- Not yet recruiting
- Hospital El Cruce
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, 1181
- Not yet recruiting
- Hospital Italiano de Buenos Aires
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Buenos Aires, Buenos Aires F.D., Argentina, C1023AAB
- Not yet recruiting
- STAT Research S.A.
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Pcia de Buenos Aires
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Pilar, Pcia de Buenos Aires, Argentina, B16290DT
- Not yet recruiting
- Hospital Universitario Austral
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Santa Fe Province
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Santa Fe, Santa Fe Province, Argentina, S2002KDS
- Not yet recruiting
- Hospital Provincial del Centenario
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Epping, Australia, 3076
- Not yet recruiting
- Northern Hospital Epping
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Fitzroy, Australia, 3065
- Recruiting
- St Vincent's Hospital
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New South Wales
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Saint Leonards, New South Wales, Australia, 2065
- Not yet recruiting
- Royal North Shore Hospital
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Westmead, New South Wales, Australia, 2145
- Not yet recruiting
- Westmead Hospital
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Queensland
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Birtinya, Queensland, Australia, 4575
- Not yet recruiting
- Sunshine Coast University Hospital
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South Brisbane, Queensland, Australia, v
- Not yet recruiting
- Mater Hospital Brisbane
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South Australia
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Adelaide, South Australia, Australia, 5112
- Not yet recruiting
- Lyell McEwin Hospital
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Adelaide, South Australia, Australia, 5000
- Not yet recruiting
- Central Adelaide Local Health Network - Royal Adelaide Hospital
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Not yet recruiting
- Austin Hospital
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Melbourne, Victoria, Australia, 3004
- Not yet recruiting
- The Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Not yet recruiting
- Sir Charles Gairdner Hospital (SCGH)
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Sankt Pölten, Austria, 3100
- Not yet recruiting
- University Hospital St. Poelten
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Not yet recruiting
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
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Styria
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Graz, Styria, Austria, 8036
- Not yet recruiting
- Medizinische Universitaetsklinik Graz
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Not yet recruiting
- Medical University Innsbruck
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Edegem, Belgium, 2650
- Not yet recruiting
- Universitair Ziekenhuis Antwerpen
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Ghent, Belgium, 9000
- Recruiting
- UZ Gent
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Leuven, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven
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Anderlecht
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Brussels, Anderlecht, Belgium, 1070
- Recruiting
- Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
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Brussels Capital
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Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
- Not yet recruiting
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
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Brasília, Brazil, 70335 900
- Not yet recruiting
- Instituto de Gestao Estrategica de Saude do Distrito Federal
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Rio de Janeiro, Brazil, 22793-334
- Not yet recruiting
- Instituto Americas
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29040-091
- Not yet recruiting
- Hospital Universitario Cassiano Antonio de Moraes
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Vitória, Espírito Santo, Brazil, 29040-091
- Not yet recruiting
- Hospital Universitario Cassiano
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 41920-900
- Not yet recruiting
- Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
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Goiás
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Goiânia, Goiás, Brazil, 74605
- Not yet recruiting
- Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30140-062
- Not yet recruiting
- Nucleo de Pesquisa Clinica NUPEC
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Not yet recruiting
- Hospital de Clinicas de Porto Alegre (HCPA)
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brazil, 21941-617
- Not yet recruiting
- Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
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SaoPaulo
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Botucatu, SaoPaulo, Brazil, 18618970
- Not yet recruiting
- Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
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São Paulo
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Not yet recruiting
- Hospital de Base - Centro Integrado de Pesquisa ( CIP )
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São Paulo, São Paulo, Brazil, 05403-000
- Not yet recruiting
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Not yet recruiting
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2X8
- Not yet recruiting
- University Of Alberta Hospital-Zeidler Ledcor Centre
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- Not yet recruiting
- (G.I.R.I) GI Research Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Not yet recruiting
- Shared Health Inc. Health Sciences Centre
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New Brunswick
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Halifax, New Brunswick, Canada, B3H2Y9
- Not yet recruiting
- Queen Elizabeth II (QEII) Health Sciences Centre -Dalhousie University-Victoria General
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- Not yet recruiting
- Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
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London, Ontario, Canada, N6A 5A5
- Not yet recruiting
- London Health Sciences Centre (LHSC) - University Hospital
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North Bay, Ontario, Canada, P1B 2H3
- Not yet recruiting
- Dr Gauthier,MD,Office Of
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Ottawa, Ontario, Canada, K1H 8L6
- Not yet recruiting
- The Ottawa Hospital - General Campus
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Toronto, Ontario, Canada, M5G 2C4
- Not yet recruiting
- University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic
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Toronto, Ontario, Canada, M6H 3M1
- Not yet recruiting
- Toronto Liver Centre
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- Not yet recruiting
- Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100032
- Not yet recruiting
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, China, 100050
- Not yet recruiting
- Beijing Friendship Hospital, Capital Medical University
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Beijing, Beijing Municipality, China, 100015
- Not yet recruiting
- Beijing Ditan Hospital
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Beijing, Beijing Municipality, China, 100044
- Not yet recruiting
- Peking University Peoples Hospital (PKUPH)
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Not yet recruiting
- Guangzhou Eighth People's Hospital
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Henan
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Zhengzhou, Henan, China, 450003
- Not yet recruiting
- Henan Provincial People's Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330000
- Not yet recruiting
- The Second Affiliated Hospital Of Nanchang University
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Jilin
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Changchun, Jilin, China, 130021
- Not yet recruiting
- The First Hospital of Jilin University
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Shandong
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Jinan, Shandong, China, 250012
- Not yet recruiting
- Qilu Hospital of Shandong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200001
- Recruiting
- Renji hospital shanghai jiao tong university school of medicine
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300052
- Not yet recruiting
- Tianjin Medical University General Hospital
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Pilsen, Czechia, 301 00
- Not yet recruiting
- Research Site s.r.o.
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Prague, Czechia, 14021
- Not yet recruiting
- Institute for Clinical and Experimental Medicine - IKEM
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Prague, Czechia, 190 00
- Recruiting
- ISCARE IVF Klinika Centrum
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Aarhus, Denmark, 8200
- Not yet recruiting
- Aarhus Universitets hospital
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Capital Region
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Copenhagen, Capital Region, Denmark, 2100
- Not yet recruiting
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Turku, Finland, 20521
- Not yet recruiting
- Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital
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Lille, France, 59000
- Not yet recruiting
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lyon, France, 69004
- Not yet recruiting
- Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
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Montpellier, France, 34295
- Not yet recruiting
- Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
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Nantes, France, 44093
- Recruiting
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
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Paris, France, 75012
- Recruiting
- Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine
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Paris, France, 75013
- Not yet recruiting
- Hopitaux Universitaires Pitie Salpetriere Charles Foix
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Toulouse, France, 31076
- Not yet recruiting
- Clinique Pasteur
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Villejuif, France, 94800
- Recruiting
- Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)
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Berlin, Germany, 13359
- Not yet recruiting
- DRK Kliniken Berlin Mitte
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Dresden, Germany, 1307
- Not yet recruiting
- Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
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Hanover, Germany, 30625
- Not yet recruiting
- Medizinische Hochschule Hannover, Hannover Medical School
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Heidelberg, Germany, 69120
- Not yet recruiting
- Universitatsklinikum Heidelberg
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Leipzig, Germany, 4103
- Not yet recruiting
- Universitaetsklinikum Leipzig
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Magdeburg, Germany, 39120
- Not yet recruiting
- Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik
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Mainz, Germany, 55131
- Not yet recruiting
- Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
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Tübingen, Germany, 72076
- Not yet recruiting
- Universitaetsklinikum Tuebingen
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Wiesbaden, Germany, 65189
- Not yet recruiting
- St. Josefs-Hospital Wiesbaden Gmbh
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Würzburg, Germany, 97080
- Not yet recruiting
- Universitaetsklinikum Wuerzburg
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Genova, Italy, 16132
- Not yet recruiting
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
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Milan, Italy, 20162
- Not yet recruiting
- ASST Grande Ospedale Metropolitano Niguarda
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Modena, Italy, 41124
- Not yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico di Modena
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Monza, Italy, 20900
- Not yet recruiting
- Ospedale San Gerardo
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Novara, Italy, 28100
- Not yet recruiting
- Azienda Ospedaliero Universitaria Maggiore della Carità
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Padova, Italy, 35128
- Not yet recruiting
- Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
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Roma, Italy, 168
- Not yet recruiting
- A. Gemelli University Hospital, Catholic University of the Sacred Heart
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Rozzano, Italy, 20089
- Not yet recruiting
- IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
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Udine, Italy, 33100
- Not yet recruiting
- ASUFC
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Tokyo, Japan, 160-8582
- Not yet recruiting
- Keio University Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8677
- Not yet recruiting
- Chiba University Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan, 734-8551
- Not yet recruiting
- Hiroshima University Hospital
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Itabashi-ku
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tabashi City, Itabashi-ku, Japan, 173-8606
- Not yet recruiting
- Teikyo University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0024
- Not yet recruiting
- Yokohama City University Medical Center
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Nagasaki
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Ōmura, Nagasaki, Japan, 856-8562
- Not yet recruiting
- National Hospital Organization Nagasaki Medical Center
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Nara
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Kashihara, Nara, Japan, 634-8522
- Not yet recruiting
- Nara Medical University Hospital
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Niigata
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Niigata, Niigata, Japan, 951-8520
- Not yet recruiting
- Niigata University Medical & Dental Hospital
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Osaka
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Suita, Osaka, Japan, 565-0871
- Not yet recruiting
- The University of Osaka Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Not yet recruiting
- Juntendo University Hospital
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Bunkyo-ku, Tokyo, Japan, 113-8655
- Not yet recruiting
- The University of Tokyo Hospital
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Amsterdam, Netherlands, 1081 HV
- Not yet recruiting
- Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
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Groningen, Netherlands, 9713 GZ
- Not yet recruiting
- University Medical Center Groningen
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Leiden, Netherlands, 2333 ZA
- Not yet recruiting
- Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
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Rotterdam, Netherlands, 3015 GD
- Not yet recruiting
- Erasmus University Medical Center
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Utrecht, Netherlands, 3584 CX
- Not yet recruiting
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GA
- Recruiting
- Radboud University Medical Center
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Bergen, Norway, 5009
- Not yet recruiting
- Haraldsplass Diakonale Sykehus
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Oslo, Norway, 372
- Recruiting
- Oslo University Hospital
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Akershus
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Lorenskog, Akershus, Norway, 1478
- Not yet recruiting
- Akershus Universitetssykehus HF
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Lublin, Poland, 20-582
- Not yet recruiting
- Medrise sp. z o.o
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Mysłowice, Poland, 41-400
- Recruiting
- ID Clinic
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Warsaw, Poland, 04-501
- Recruiting
- Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Coimbra, Portugal, 3000-075
- Not yet recruiting
- Centro Hospitalar E Universitario de Coimbra EPE
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Lisbon, Portugal, 1649-035
- Not yet recruiting
- Hospital Santa Maria
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Porto, Portugal, 4100-180
- Not yet recruiting
- CUF Porto Hospital
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Lisbon District
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Lisbon, Lisbon District, Portugal, 1500-650
- Not yet recruiting
- Hospital da Luz Lisboa
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Lisbon, Lisbon District, Portugal, 1150-199
- Not yet recruiting
- Unidade Local De Saude De Sao Jose E.P.E.
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Porto District
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Porto, Porto District, Portugal, 4050-011
- Not yet recruiting
- Unidade Local de Saude de Santo Antonio
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Bucharest, Romania, 20475
- Recruiting
- Spital Clinic Dr I Cantacuzino
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Bucharest, Romania, 22328
- Not yet recruiting
- Institutul Clinic Fundeni
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Iași, Romania, 700111
- Recruiting
- Gastromedica Srl
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Jud Satu-Mare
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Satu Mare, Jud Satu-Mare, Romania
- Recruiting
- Spitalul Judetean de Urgenta Satu Mare
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Jud. Cluj
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Cluj-Napoca, Jud. Cluj, Romania, 400132
- Recruiting
- Spitalul Clinic De Urgenta Prof. Dr. Octavian Fodor
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Busan, South Korea, 49241
- Not yet recruiting
- Pusan National University Hospital (PNUH)
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Seoul, South Korea, Seoul
- Not yet recruiting
- Samsung Medical Center
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Seoul, South Korea, Seoul
- Not yet recruiting
- Seoul National University Hospital
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Seoul
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Seoul, Seoul, South Korea, 5505
- Not yet recruiting
- Asan Medical Center (AMC)
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Barcelona, Spain, 8036
- Recruiting
- Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
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Barcelona, Spain, 8003
- Not yet recruiting
- Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)
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Barcelona, Spain, 8035
- Not yet recruiting
- Vall de Hebron University Hospital
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Córdoba, Spain, 14004
- Not yet recruiting
- Hospital Universitario Reina Sofia
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
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Madrid, Spain, 28046
- Not yet recruiting
- Hospital Universitario La Paz
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Madrid, Spain, 28007
- Not yet recruiting
- Hospital General Universitario Gregorio Maranon (HGUGM)
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Pontevedra, Spain, 36071
- Not yet recruiting
- Hospital De Montecelo
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Santander, Spain, 39008
- Not yet recruiting
- Instituto De Investigacion Marques De Valdecilla (IDIVAL)
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Valencia, Spain, 46026
- Recruiting
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
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Zaragoza, Spain, 50009
- Not yet recruiting
- Hospital Universitario Miguel Servet de Zaragoza
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Gothenburg, Sweden, 413 45
- Not yet recruiting
- Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset
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Stockholm, Sweden, 141 86
- Not yet recruiting
- Karolinska Universitetssjukhuset
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Uppsala, Sweden, 751 85
- Not yet recruiting
- Akademiska Sjukhuset - Uppsala University Hospital
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Örebro, Sweden, 702 21
- Not yet recruiting
- Orebro University Hospital
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Basel, Switzerland, 4031
- Not yet recruiting
- University Hospital Basel
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Bern, Switzerland, 3010
- Not yet recruiting
- Universitaetsspital Bern - Inselspital
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Lugano, Switzerland, 6900
- Not yet recruiting
- Ospedale Civico
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Zurich, Switzerland, 8091
- Not yet recruiting
- Universitatsspital Zurich
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Aberdeen, United Kingdom, AB25 2ZD
- Not yet recruiting
- Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
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Birmingham, United Kingdom, B15 2TT
- Not yet recruiting
- Queen Elizabeth Hospital
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Glasgow, United Kingdom, G4 0SF
- Not yet recruiting
- NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)
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London, United Kingdom, E1 1FR
- Not yet recruiting
- The Royal London Hospital - Barts Health NHS Trust
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Not yet recruiting
- Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Camberley
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Frimley, Camberley, United Kingdom, GU16 7UJ
- Not yet recruiting
- Frimley Park Hospital - Frimley Health NHS Foundation Trust
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Greater London
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London, Greater London, United Kingdom, SE5 9RS
- Not yet recruiting
- King's College Hospital
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London, Greater London, United Kingdom, NW3 2QG
- Not yet recruiting
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 7UY
- Not yet recruiting
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Not yet recruiting
- John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
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Yorkshire and the Humber
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Cottingham, Yorkshire and the Humber, United Kingdom, HU16 5JQ
- Not yet recruiting
- Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology
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Arizona
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Chandler, Arizona, United States, 85224
- Recruiting
- Arizona Liver Health
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Phoenix, Arizona, United States, 85054
- Not yet recruiting
- Mayo Clinic in Arizona
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California
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Coronado, California, United States, 92118
- Recruiting
- Southern California Research Center
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La Jolla, California, United States, 92037-0897
- Not yet recruiting
- University of California San Diego
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Los Angeles, California, United States, 90048
- Not yet recruiting
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90033
- Not yet recruiting
- Keck Medicine of USC - USC Healthcare Center 1
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Pasadena, California, United States, 91105
- Recruiting
- California Liver Research Institute
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Redwood City, California, United States, 94063
- Not yet recruiting
- Stanford University
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Sacramento, California, United States, 95817
- Not yet recruiting
- University of California Davis Medical Center
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San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco Medical Center
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San Francisco, California, United States, 94109
- Not yet recruiting
- Sutter Health Van Ness Campus Medical Office Building
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- University of Colorado Hospital Anschutz Outpatient Pavilion
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Colorado Springs, Colorado, United States, 80920
- Recruiting
- Peak Gastroenterology Associates
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Englewood, Colorado, United States, 80113
- Recruiting
- South Denver Gastroenterology,P.C.
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Littleton, Colorado, United States, 90046
- Recruiting
- Rocky Mountain Gastroenterology (RMG)
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Connecticut
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New Haven, Connecticut, United States, 06510-2738
- Not yet recruiting
- Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
- Not yet recruiting
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami - Schiff Center for Liver Diseases
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Georgia
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Atlanta, Georgia, United States, 30309
- Not yet recruiting
- Piedmont Hospital - Piedmont Transplant Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Not yet recruiting
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- Not yet recruiting
- The University of Chicago Medicine
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Chicago, Illinois, United States, 60611
- Not yet recruiting
- Northwestern Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University School of Medicine
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New Albany, Indiana, United States, 47150
- Not yet recruiting
- Gastroenterology Health Partners, PLLC (Southern Indiana Location)
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Newburgh, Indiana, United States, 47630
- Not yet recruiting
- Deaconess GI Specialty Center
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- The University of Iowa Hospitals & Clinics
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Kentucky
-
Louisville, Kentucky, United States, 40202
- Not yet recruiting
- University Of Louisville School Of Medicine
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-
Maryland
-
Baltimore, Maryland, United States, 21202
- Recruiting
- Mercy Medical Center, Inc
-
Baltimore, Maryland, United States, 21287
- Not yet recruiting
- Johns Hopkins University School of Medicine
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Beth Israel Deaconess Medical Center
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-
Michigan
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Ann Arbor, Michigan, United States, 48109
- Not yet recruiting
- University of Michigan
-
Detroit, Michigan, United States, 48202
- Not yet recruiting
- Henry Ford Health System
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Not yet recruiting
- Mayo Clinic Cancer Center (MCCC) - Rochester
-
-
Missouri
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St Louis, Missouri, United States, 63104-1015
- Not yet recruiting
- Saint Louis University
-
-
Nebraska
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Omaha, Nebraska, United States, 68198
- Not yet recruiting
- University of Nebraska Medical Center
-
-
New York
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New York, New York, United States, 10029
- Not yet recruiting
- Mount Sinai Medical Center
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New York, New York, United States, 10016
- Not yet recruiting
- NYU Langone Gastroenterology and Hepatology Associates
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New York, New York, United States, 10021
- Not yet recruiting
- Weill Medical College Of Cornell University
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Rochester, New York, United States, 14642
- Not yet recruiting
- University of Rochester Medical Center
-
-
North Carolina
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Asheville, North Carolina, United States, 28803
- Not yet recruiting
- Digestive Health Partners, PA
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Chapel Hill, North Carolina, United States, 27599-7584
- Not yet recruiting
- The University of North Carolina at Chapel Hill
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Charlotte, North Carolina, United States, 28204
- Not yet recruiting
- Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
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Durham, North Carolina, United States, 27710
- Not yet recruiting
- Duke University Health System
-
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Ohio
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Beavercreek, Ohio, United States, 45440
- Not yet recruiting
- Dayton Gastroenterology- Englewood
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Cleveland, Ohio, United States, 44106
- Not yet recruiting
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, United States, 44195-0001
- Not yet recruiting
- Cleveland Clinic Foundation
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Not yet recruiting
- Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
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Philadelphia, Pennsylvania, United States, 19104
- Not yet recruiting
- University of Pennsylvania - Perelman Center for Advanced Medicine
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Philadelphia, Pennsylvania, United States, 19107-5244
- Not yet recruiting
- Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
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Rhode Island
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Providence, Rhode Island, United States, 02904
- Recruiting
- University Gastroenterology
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-
South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina (MUSC)
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-
South Dakota
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Rapid City, South Dakota, United States, 57701
- Not yet recruiting
- Rapid City Medical Center
-
-
Tennessee
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Cordova, Tennessee, United States, 38018
- Recruiting
- Gastro One
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Johnson City, Tennessee, United States, 37604
- Recruiting
- Gastrointestinal Associates of Northeast Tennessee
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Texas
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Dallas, Texas, United States, 75390-9045
- Not yet recruiting
- University of Texas Southwestern Medical Center
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Dallas, Texas, United States, 75203
- Recruiting
- Methodist Health Systems Clinical Research Institute
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Houston, Texas, United States, 77030
- Not yet recruiting
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- Recruiting
- Liver Associates of Texas, P.A.
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Houston, Texas, United States, 77030
- Not yet recruiting
- Baylor College of Medicine - Advanced Liver Therapies
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San Antonio, Texas, United States, 78215
- Recruiting
- American Research Corporation at The Texas Liver Institute
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San Antonio, Texas, United States, 78251
- Recruiting
- Starhope Liver Center, PA - Starhope Clinical Research, LLC
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Utah
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Murray, Utah, United States, 84107
- Not yet recruiting
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia Medical Center
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Richmond, Virginia, United States, 23226
- Not yet recruiting
- Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
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Richmond, Virginia, United States, 23298-0341
- Not yet recruiting
- Virginia Commonwealth University Medical Center
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Washington
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Bellevue, Washington, United States, 98004
- Not yet recruiting
- Northwest Gastroenterology Associates
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Seattle, Washington, United States, 98105
- Recruiting
- Velocity Clinical Research, Seattle
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Not yet recruiting
- University of Wisconsin Hospitals and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults participants aged 18 years or older
- Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- Compensated liver disease at screening
- Stable background therapy, where applicable prior to study entry
- Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
- Ability to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- History or presence of other concomitant chronic liver disease
- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment.
ii) Evidence of complications of cirrhosis
-
Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.
-
History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
-
History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
-
History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma
-
Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
-
Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
-
Administration of the following medications are prohibited as specified below:
i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones.
ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).
- Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor.
- Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) >450 msec in males or QTcF >470 msec in females for participants without bundle branch block.
- Significant renal disease,
- For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
- Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women
- History of alcohol abuse, or other substance abuse within 1 year prior to SV.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.
- Mental instability or incompetence
- Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
- Medical conditions that may diminish life expectancy to <2 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Elafibranor 120 mg
Participants will take 1 tablet of elafibranor 120 mg orally once daily |
Round and orange film coated tablet of 120 mg
Other Names:
|
|
Placebo Comparator: Placebo
Participants will take 1 placebo tablet orally once daily |
Round and orange film coated tablet of placebo |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event-Free Survival
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first. |
From baseline until the end of treatment (estimated up to 5 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants developing cholangiocarcinoma (CCA), hepatocellular carcinoma (HCC), or colorectal cancer (CRC)
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
From baseline until the end of treatment (estimated up to 5 years)
|
|
|
Percentage of participants with ALP level within the pre-defined level
Time Frame: From baseline to Week 48
|
Difference between elafibranor and placebo in the percentage of participants with alkaline phosphatase (ALP) within the pre-defined level at Week 48. |
From baseline to Week 48
|
|
Change from baseline in severity of a patient-reported cholestatic symptom: Pruritus
Time Frame: From baseline to Week 24
|
Symptom will be assessed using a patient-reported outcome scale |
From baseline to Week 24
|
|
Change from baseline in severity of a patient-reported cholestatic symptom: Fatigue
Time Frame: From baseline to Week 48
|
Symptom will be assessed using a patient-reported outcome scale |
From baseline to Week 48
|
|
Percentage of participants experiencing treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs |
From baseline until the end of treatment (estimated up to 5 years)
|
|
Percentage of participants developing clinically significant changes in physical examination findings
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
The clinical significance will be graded by the investigator |
From baseline until the end of treatment (estimated up to 5 years)
|
|
Percentage of participants developing clinically significant changes in vital signs
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
The clinical significance will be graded by the investigator |
From baseline until the end of treatment (estimated up to 5 years)
|
|
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) readings.
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
The clinical significance will be graded by the investigator |
From baseline until the end of treatment (estimated up to 5 years)
|
|
Percentage of participants with clinically significant changes in laboratory parameters (blood chemistry, hematology, coagulation and urinalysis)
Time Frame: From baseline until the end of treatment (estimated up to 5 years)
|
The clinical significance will be graded by the investigator |
From baseline until the end of treatment (estimated up to 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2026
Primary Completion (Estimated)
April 30, 2031
Study Completion (Estimated)
May 31, 2031
Study Registration Dates
First Submitted
January 28, 2026
First Submitted That Met QC Criteria
January 28, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
October 23, 2026
Last Update Submitted That Met QC Criteria
October 20, 2026
Last Verified
October 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-60190-475
- 2026-525242-29-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.