Et studie til at vurdere, hvor godt og sikkert Elafibranor virker hos voksne deltagere med primær skleroserende kolangitis (ELASCOPE)
20. oktober 2026 opdateret af: Ipsen
En fase III, multicentrisk, randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af Elafibranor hos voksne deltagere med primær skleroserende kolangitis
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
350
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ipsen Clinical Study Enquiries
- Telefonnummer: see email
- E-mail: clinical.trials@ipsen.com
Studiesteder
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Ikke rekrutterer endnu
- GEDYT (Gastroenterologia Diagnostica y Terapeutica)
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San Juan Bautista, Buenos Aires, Argentina, 1888
- Ikke rekrutterer endnu
- Hospital El Cruce
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, 1181
- Ikke rekrutterer endnu
- Hospital Italiano de Buenos Aires
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Buenos Aires, Buenos Aires F.D., Argentina, C1023AAB
- Ikke rekrutterer endnu
- STAT Research S.A.
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Pcia de Buenos Aires
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Pilar, Pcia de Buenos Aires, Argentina, B16290DT
- Ikke rekrutterer endnu
- Hospital Universitario Austral
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Santa Fe Province
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Santa Fe, Santa Fe Province, Argentina, S2002KDS
- Ikke rekrutterer endnu
- Hospital Provincial del Centenario
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Epping, Australien, 3076
- Ikke rekrutterer endnu
- Northern Hospital Epping
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Fitzroy, Australien, 3065
- Rekruttering
- St Vincent's Hospital
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New South Wales
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Saint Leonards, New South Wales, Australien, 2065
- Ikke rekrutterer endnu
- Royal North Shore Hospital
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Westmead, New South Wales, Australien, 2145
- Ikke rekrutterer endnu
- Westmead Hospital
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Queensland
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Birtinya, Queensland, Australien, 4575
- Ikke rekrutterer endnu
- Sunshine Coast University Hospital
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South Brisbane, Queensland, Australien, v
- Ikke rekrutterer endnu
- Mater Hospital Brisbane
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South Australia
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Adelaide, South Australia, Australien, 5112
- Ikke rekrutterer endnu
- Lyell McEwin Hospital
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Adelaide, South Australia, Australien, 5000
- Ikke rekrutterer endnu
- Central Adelaide Local Health Network - Royal Adelaide Hospital
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Ikke rekrutterer endnu
- Austin Hospital
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Melbourne, Victoria, Australien, 3004
- Ikke rekrutterer endnu
- The Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- Ikke rekrutterer endnu
- Sir Charles Gairdner Hospital (SCGH)
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Edegem, Belgien, 2650
- Ikke rekrutterer endnu
- Universitair Ziekenhuis Antwerpen
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Ghent, Belgien, 9000
- Rekruttering
- UZ Gent
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Anderlecht
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Brussels, Anderlecht, Belgien, 1070
- Rekruttering
- Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
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Brussels Capital
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Woluwe-Saint-Lambert, Brussels Capital, Belgien, 1200
- Ikke rekrutterer endnu
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
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Brasília, Brasilien, 70335 900
- Ikke rekrutterer endnu
- Instituto de Gestao Estrategica de Saude do Distrito Federal
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Rio de Janeiro, Brasilien, 22793-334
- Ikke rekrutterer endnu
- Instituto Americas
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Espírito Santo
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Vitória, Espírito Santo, Brasilien, 29040-091
- Ikke rekrutterer endnu
- Hospital Universitario Cassiano Antonio de Moraes
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Vitória, Espírito Santo, Brasilien, 29040-091
- Ikke rekrutterer endnu
- Hospital Universitario Cassiano
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 41920-900
- Ikke rekrutterer endnu
- Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
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Goiás
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Goiânia, Goiás, Brasilien, 74605
- Ikke rekrutterer endnu
- Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30140-062
- Ikke rekrutterer endnu
- Nucleo de Pesquisa Clinica NUPEC
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Ikke rekrutterer endnu
- Hospital de Clinicas de Porto Alegre (HCPA)
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasilien, 21941-617
- Ikke rekrutterer endnu
- Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
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SaoPaulo
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Botucatu, SaoPaulo, Brasilien, 18618970
- Ikke rekrutterer endnu
- 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, Brasilien, 15090-000
- Ikke rekrutterer endnu
- Hospital de Base - Centro Integrado de Pesquisa ( CIP )
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São Paulo, São Paulo, Brasilien, 05403-000
- Ikke rekrutterer endnu
- 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
- Ikke rekrutterer endnu
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2X8
- Ikke rekrutterer endnu
- University Of Alberta Hospital-Zeidler Ledcor Centre
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- Ikke rekrutterer endnu
- (G.I.R.I) GI Research Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Ikke rekrutterer endnu
- Shared Health Inc. Health Sciences Centre
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New Brunswick
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Halifax, New Brunswick, Canada, B3H2Y9
- Ikke rekrutterer endnu
- 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
- Ikke rekrutterer endnu
- Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
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London, Ontario, Canada, N6A 5A5
- Ikke rekrutterer endnu
- London Health Sciences Centre (LHSC) - University Hospital
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North Bay, Ontario, Canada, P1B 2H3
- Ikke rekrutterer endnu
- Dr Gauthier,MD,Office Of
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Ottawa, Ontario, Canada, K1H 8L6
- Ikke rekrutterer endnu
- The Ottawa Hospital - General Campus
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Toronto, Ontario, Canada, M5G 2C4
- Ikke rekrutterer endnu
- University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic
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Toronto, Ontario, Canada, M6H 3M1
- Ikke rekrutterer endnu
- Toronto Liver Centre
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- Ikke rekrutterer endnu
- Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
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Aarhus, Danmark, 8200
- Ikke rekrutterer endnu
- Aarhus Universitets hospital
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Capital Region
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Copenhagen, Capital Region, Danmark, 2100
- Ikke rekrutterer endnu
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Aberdeen, Det Forenede Kongerige, AB25 2ZD
- Ikke rekrutterer endnu
- Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
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Birmingham, Det Forenede Kongerige, B15 2TT
- Ikke rekrutterer endnu
- Queen Elizabeth Hospital
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Glasgow, Det Forenede Kongerige, G4 0SF
- Ikke rekrutterer endnu
- NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)
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London, Det Forenede Kongerige, E1 1FR
- Ikke rekrutterer endnu
- The Royal London Hospital - Barts Health NHS Trust
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Ikke rekrutterer endnu
- Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Camberley
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Frimley, Camberley, Det Forenede Kongerige, GU16 7UJ
- Ikke rekrutterer endnu
- Frimley Park Hospital - Frimley Health NHS Foundation Trust
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Greater London
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London, Greater London, Det Forenede Kongerige, SE5 9RS
- Ikke rekrutterer endnu
- King's College Hospital
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London, Greater London, Det Forenede Kongerige, NW3 2QG
- Ikke rekrutterer endnu
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Norfolk
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Norwich, Norfolk, Det Forenede Kongerige, NR4 7UY
- Ikke rekrutterer endnu
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
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Oxfordshire
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Oxford, Oxfordshire, Det Forenede Kongerige, OX3 9DU
- Ikke rekrutterer endnu
- 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, Det Forenede Kongerige, HU16 5JQ
- Ikke rekrutterer endnu
- Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology
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Turku, Finland, 20521
- Ikke rekrutterer endnu
- Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Arizona Liver Health
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Phoenix, Arizona, Forenede Stater, 85054
- Ikke rekrutterer endnu
- Mayo Clinic in Arizona
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California
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Coronado, California, Forenede Stater, 92118
- Rekruttering
- Southern California Research Center
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La Jolla, California, Forenede Stater, 92037-0897
- Ikke rekrutterer endnu
- University of California San Diego
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Los Angeles, California, Forenede Stater, 90048
- Ikke rekrutterer endnu
- Cedars-Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90033
- Ikke rekrutterer endnu
- Keck Medicine of USC - USC Healthcare Center 1
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Pasadena, California, Forenede Stater, 91105
- Rekruttering
- California Liver Research Institute
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Redwood City, California, Forenede Stater, 94063
- Ikke rekrutterer endnu
- Stanford University
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Sacramento, California, Forenede Stater, 95817
- Ikke rekrutterer endnu
- University of California Davis Medical Center
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San Francisco, California, Forenede Stater, 94143
- Rekruttering
- University of California, San Francisco Medical Center
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San Francisco, California, Forenede Stater, 94109
- Ikke rekrutterer endnu
- Sutter Health Van Ness Campus Medical Office Building
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Ikke rekrutterer endnu
- University of Colorado Hospital Anschutz Outpatient Pavilion
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Colorado Springs, Colorado, Forenede Stater, 80920
- Rekruttering
- Peak Gastroenterology Associates
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Englewood, Colorado, Forenede Stater, 80113
- Rekruttering
- South Denver Gastroenterology,P.C.
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Littleton, Colorado, Forenede Stater, 90046
- Rekruttering
- Rocky Mountain Gastroenterology (RMG)
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510-2738
- Ikke rekrutterer endnu
- 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, Forenede Stater, 20007
- Ikke rekrutterer endnu
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
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Florida
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami - Schiff Center for Liver Diseases
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Ikke rekrutterer endnu
- Piedmont Hospital - Piedmont Transplant Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Ikke rekrutterer endnu
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- Ikke rekrutterer endnu
- The University of Chicago Medicine
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Chicago, Illinois, Forenede Stater, 60611
- Ikke rekrutterer endnu
- Northwestern Medicine
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University School of Medicine
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New Albany, Indiana, Forenede Stater, 47150
- Ikke rekrutterer endnu
- Gastroenterology Health Partners, PLLC (Southern Indiana Location)
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Newburgh, Indiana, Forenede Stater, 47630
- Ikke rekrutterer endnu
- Deaconess GI Specialty Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- The University of Iowa Hospitals & Clinics
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Ikke rekrutterer endnu
- University Of Louisville School Of Medicine
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
- Rekruttering
- Mercy Medical Center, Inc
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Baltimore, Maryland, Forenede Stater, 21287
- Ikke rekrutterer endnu
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ikke rekrutterer endnu
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02215
- Ikke rekrutterer endnu
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Ikke rekrutterer endnu
- University of Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Ikke rekrutterer endnu
- Henry Ford Health System
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Ikke rekrutterer endnu
- Mayo Clinic Cancer Center (MCCC) - Rochester
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Missouri
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St Louis, Missouri, Forenede Stater, 63104-1015
- Ikke rekrutterer endnu
- Saint Louis University
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Ikke rekrutterer endnu
- University of Nebraska Medical Center
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New York
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New York, New York, Forenede Stater, 10029
- Ikke rekrutterer endnu
- Mount Sinai Medical Center
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New York, New York, Forenede Stater, 10016
- Ikke rekrutterer endnu
- NYU Langone Gastroenterology and Hepatology Associates
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New York, New York, Forenede Stater, 10021
- Ikke rekrutterer endnu
- Weill Medical College Of Cornell University
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Rochester, New York, Forenede Stater, 14642
- Ikke rekrutterer endnu
- University of Rochester Medical Center
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Ikke rekrutterer endnu
- Digestive Health Partners, PA
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Chapel Hill, North Carolina, Forenede Stater, 27599-7584
- Ikke rekrutterer endnu
- The University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28204
- Ikke rekrutterer endnu
- Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
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Durham, North Carolina, Forenede Stater, 27710
- Ikke rekrutterer endnu
- Duke University Health System
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Ohio
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Beavercreek, Ohio, Forenede Stater, 45440
- Ikke rekrutterer endnu
- Dayton Gastroenterology- Englewood
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Cleveland, Ohio, Forenede Stater, 44106
- Ikke rekrutterer endnu
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forenede Stater, 44195-0001
- Ikke rekrutterer endnu
- Cleveland Clinic Foundation
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Ikke rekrutterer endnu
- Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Ikke rekrutterer endnu
- University of Pennsylvania - Perelman Center for Advanced Medicine
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5244
- Ikke rekrutterer endnu
- Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02904
- Rekruttering
- University Gastroenterology
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- Medical University of South Carolina (MUSC)
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Ikke rekrutterer endnu
- Rapid City Medical Center
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Tennessee
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Cordova, Tennessee, Forenede Stater, 38018
- Rekruttering
- Gastro One
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Johnson City, Tennessee, Forenede Stater, 37604
- Rekruttering
- Gastrointestinal Associates of Northeast Tennessee
-
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Texas
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Dallas, Texas, Forenede Stater, 75390-9045
- Ikke rekrutterer endnu
- University of Texas Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75203
- Rekruttering
- Methodist Health Systems Clinical Research Institute
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Houston, Texas, Forenede Stater, 77030
- Ikke rekrutterer endnu
- Houston Methodist Hospital
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Liver Associates of Texas, P.A.
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Houston, Texas, Forenede Stater, 77030
- Ikke rekrutterer endnu
- Baylor College of Medicine - Advanced Liver Therapies
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San Antonio, Texas, Forenede Stater, 78215
- Rekruttering
- American Research Corporation at The Texas Liver Institute
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San Antonio, Texas, Forenede Stater, 78251
- Rekruttering
- Starhope Liver Center, PA - Starhope Clinical Research, LLC
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Utah
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Murray, Utah, Forenede Stater, 84107
- Ikke rekrutterer endnu
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- Rekruttering
- University of Virginia Medical Center
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Richmond, Virginia, Forenede Stater, 23226
- Ikke rekrutterer endnu
- Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
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Richmond, Virginia, Forenede Stater, 23298-0341
- Ikke rekrutterer endnu
- Virginia Commonwealth University Medical Center
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Washington
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Bellevue, Washington, Forenede Stater, 98004
- Ikke rekrutterer endnu
- Northwest Gastroenterology Associates
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Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- Velocity Clinical Research, Seattle
-
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Ikke rekrutterer endnu
- University of Wisconsin Hospitals and Clinics
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-
-
-
-
Lille, Frankrig, 59000
- Ikke rekrutterer endnu
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lyon, Frankrig, 69004
- Ikke rekrutterer endnu
- Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
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Montpellier, Frankrig, 34295
- Ikke rekrutterer endnu
- Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
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Nantes, Frankrig, 44093
- Rekruttering
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
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Paris, Frankrig, 75012
- Rekruttering
- Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine
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Paris, Frankrig, 75013
- Ikke rekrutterer endnu
- Hopitaux Universitaires Pitie Salpetriere Charles Foix
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Toulouse, Frankrig, 31076
- Ikke rekrutterer endnu
- Clinique Pasteur
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Villejuif, Frankrig, 94800
- Rekruttering
- Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)
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-
-
-
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Amsterdam, Holland, 1081 HV
- Ikke rekrutterer endnu
- Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
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Groningen, Holland, 9713 GZ
- Ikke rekrutterer endnu
- University Medical Center Groningen
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Leiden, Holland, 2333 ZA
- Ikke rekrutterer endnu
- Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
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Rotterdam, Holland, 3015 GD
- Ikke rekrutterer endnu
- Erasmus University Medical Center
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Utrecht, Holland, 3584 CX
- Ikke rekrutterer endnu
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Gelderland
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Nijmegen, Gelderland, Holland, 6525 GA
- Rekruttering
- Radboud University Medical Center
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-
-
-
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Genova, Italien, 16132
- Ikke rekrutterer endnu
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
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Milan, Italien, 20162
- Ikke rekrutterer endnu
- ASST Grande Ospedale Metropolitano Niguarda
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Modena, Italien, 41124
- Ikke rekrutterer endnu
- Azienda Ospedaliero-Universitaria Policlinico di Modena
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Monza, Italien, 20900
- Ikke rekrutterer endnu
- Ospedale San Gerardo
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Novara, Italien, 28100
- Ikke rekrutterer endnu
- Azienda Ospedaliero Universitaria Maggiore della Carità
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Padova, Italien, 35128
- Ikke rekrutterer endnu
- Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
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Roma, Italien, 168
- Ikke rekrutterer endnu
- A. Gemelli University Hospital, Catholic University of the Sacred Heart
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Rozzano, Italien, 20089
- Ikke rekrutterer endnu
- IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
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Udine, Italien, 33100
- Ikke rekrutterer endnu
- ASUFC
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-
-
-
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Tokyo, Japan, 160-8582
- Ikke rekrutterer endnu
- Keio University Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8677
- Ikke rekrutterer endnu
- Chiba University Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan, 734-8551
- Ikke rekrutterer endnu
- Hiroshima University Hospital
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Itabashi-ku
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tabashi City, Itabashi-ku, Japan, 173-8606
- Ikke rekrutterer endnu
- Teikyo University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0024
- Ikke rekrutterer endnu
- Yokohama City University Medical Center
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Nagasaki
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Ōmura, Nagasaki, Japan, 856-8562
- Ikke rekrutterer endnu
- National Hospital Organization Nagasaki Medical Center
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Nara
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Kashihara, Nara, Japan, 634-8522
- Ikke rekrutterer endnu
- Nara Medical University Hospital
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Niigata
-
Niigata, Niigata, Japan, 951-8520
- Ikke rekrutterer endnu
- Niigata University Medical & Dental Hospital
-
-
Osaka
-
Suita, Osaka, Japan, 565-0871
- Ikke rekrutterer endnu
- The University of Osaka Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Ikke rekrutterer endnu
- Juntendo University Hospital
-
Bunkyo-ku, Tokyo, Japan, 113-8655
- Ikke rekrutterer endnu
- The University of Tokyo Hospital
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100032
- Ikke rekrutterer endnu
- Peking Union Medical College Hospital
-
Beijing, Beijing Municipality, Kina, 100050
- Ikke rekrutterer endnu
- Beijing Friendship Hospital, Capital Medical University
-
Beijing, Beijing Municipality, Kina, 100015
- Ikke rekrutterer endnu
- Beijing Ditan Hospital
-
Beijing, Beijing Municipality, Kina, 100044
- Ikke rekrutterer endnu
- Peking University Peoples Hospital (PKUPH)
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Ikke rekrutterer endnu
- Guangzhou Eighth People's Hospital
-
-
Henan
-
Zhengzhou, Henan, Kina, 450003
- Ikke rekrutterer endnu
- Henan Provincial People's Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330000
- Ikke rekrutterer endnu
- The Second Affiliated Hospital Of Nanchang University
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- Ikke rekrutterer endnu
- The First Hospital of Jilin University
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Ikke rekrutterer endnu
- Qilu Hospital of Shandong University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200001
- Rekruttering
- Renji hospital shanghai jiao tong university school of medicine
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300052
- Ikke rekrutterer endnu
- Tianjin Medical University General Hospital
-
-
-
-
-
Bergen, Norge, 5009
- Ikke rekrutterer endnu
- Haraldsplass Diakonale Sykehus
-
Oslo, Norge, 372
- Rekruttering
- Oslo University Hospital
-
-
Akershus
-
Lorenskog, Akershus, Norge, 1478
- Ikke rekrutterer endnu
- Akershus Universitetssykehus HF
-
-
-
-
-
Lublin, Polen, 20-582
- Ikke rekrutterer endnu
- Medrise sp. z o.o
-
Mysłowice, Polen, 41-400
- Rekruttering
- ID Clinic
-
Warsaw, Polen, 04-501
- Rekruttering
- Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
-
-
-
-
-
Coimbra, Portugal, 3000-075
- Ikke rekrutterer endnu
- Centro Hospitalar E Universitario de Coimbra EPE
-
Lisbon, Portugal, 1649-035
- Ikke rekrutterer endnu
- Hospital Santa Maria
-
Porto, Portugal, 4100-180
- Ikke rekrutterer endnu
- CUF Porto Hospital
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal, 1500-650
- Ikke rekrutterer endnu
- Hospital da Luz Lisboa
-
Lisbon, Lisbon District, Portugal, 1150-199
- Ikke rekrutterer endnu
- Unidade Local De Saude De Sao Jose E.P.E.
-
-
Porto District
-
Porto, Porto District, Portugal, 4050-011
- Ikke rekrutterer endnu
- Unidade Local de Saude de Santo Antonio
-
-
-
-
-
Bucharest, Rumænien, 20475
- Rekruttering
- Spital Clinic Dr I Cantacuzino
-
Bucharest, Rumænien, 22328
- Ikke rekrutterer endnu
- Institutul Clinic Fundeni
-
Iași, Rumænien, 700111
- Rekruttering
- Gastromedica Srl
-
-
Jud Satu-Mare
-
Satu Mare, Jud Satu-Mare, Rumænien
- Rekruttering
- Spitalul Judetean de Urgenta Satu Mare
-
-
Jud. Cluj
-
Cluj-Napoca, Jud. Cluj, Rumænien, 400132
- Rekruttering
- Spitalul Clinic De Urgenta Prof. Dr. Octavian Fodor
-
-
-
-
-
Basel, Schweiz, 4031
- Ikke rekrutterer endnu
- University Hospital Basel
-
Bern, Schweiz, 3010
- Ikke rekrutterer endnu
- Universitaetsspital Bern - Inselspital
-
Lugano, Schweiz, 6900
- Ikke rekrutterer endnu
- Ospedale Civico
-
Zurich, Schweiz, 8091
- Ikke rekrutterer endnu
- Universitatsspital Zurich
-
-
-
-
-
Barcelona, Spanien, 8036
- Rekruttering
- Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
-
Barcelona, Spanien, 8003
- Ikke rekrutterer endnu
- Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)
-
Barcelona, Spanien, 8035
- Ikke rekrutterer endnu
- Vall de Hebron University Hospital
-
Córdoba, Spanien, 14004
- Ikke rekrutterer endnu
- Hospital Universitario Reina Sofia
-
Madrid, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
-
Madrid, Spanien, 28046
- Ikke rekrutterer endnu
- Hospital Universitario La Paz
-
Madrid, Spanien, 28007
- Ikke rekrutterer endnu
- Hospital General Universitario Gregorio Maranon (HGUGM)
-
Pontevedra, Spanien, 36071
- Ikke rekrutterer endnu
- Hospital De Montecelo
-
Santander, Spanien, 39008
- Ikke rekrutterer endnu
- Instituto De Investigacion Marques De Valdecilla (IDIVAL)
-
Valencia, Spanien, 46026
- Rekruttering
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Zaragoza, Spanien, 50009
- Ikke rekrutterer endnu
- Hospital Universitario Miguel Servet de Zaragoza
-
-
-
-
-
Gothenburg, Sverige, 413 45
- Ikke rekrutterer endnu
- Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset
-
Stockholm, Sverige, 141 86
- Ikke rekrutterer endnu
- Karolinska Universitetssjukhuset
-
Uppsala, Sverige, 751 85
- Ikke rekrutterer endnu
- Akademiska Sjukhuset - Uppsala University Hospital
-
Örebro, Sverige, 702 21
- Ikke rekrutterer endnu
- Orebro University Hospital
-
-
-
-
-
Busan, Sydkorea, 49241
- Ikke rekrutterer endnu
- Pusan National University Hospital (PNUH)
-
Seoul, Sydkorea, Seoul
- Ikke rekrutterer endnu
- Samsung Medical Center
-
Seoul, Sydkorea, Seoul
- Ikke rekrutterer endnu
- Seoul National University Hospital
-
-
Seoul
-
Seoul, Seoul, Sydkorea, 5505
- Ikke rekrutterer endnu
- Asan Medical Center (AMC)
-
-
-
-
-
Pilsen, Tjekkiet, 301 00
- Ikke rekrutterer endnu
- Research Site s.r.o.
-
Prague, Tjekkiet, 14021
- Ikke rekrutterer endnu
- Institute for Clinical and Experimental Medicine - IKEM
-
Prague, Tjekkiet, 190 00
- Rekruttering
- ISCARE IVF Klinika Centrum
-
-
-
-
-
Berlin, Tyskland, 13359
- Ikke rekrutterer endnu
- DRK Kliniken Berlin Mitte
-
Dresden, Tyskland, 1307
- Ikke rekrutterer endnu
- Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
-
Hanover, Tyskland, 30625
- Ikke rekrutterer endnu
- Medizinische Hochschule Hannover, Hannover Medical School
-
Heidelberg, Tyskland, 69120
- Ikke rekrutterer endnu
- Universitatsklinikum Heidelberg
-
Leipzig, Tyskland, 4103
- Ikke rekrutterer endnu
- Universitaetsklinikum Leipzig
-
Magdeburg, Tyskland, 39120
- Ikke rekrutterer endnu
- Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik
-
Mainz, Tyskland, 55131
- Ikke rekrutterer endnu
- Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
-
Tübingen, Tyskland, 72076
- Ikke rekrutterer endnu
- Universitaetsklinikum Tuebingen
-
Wiesbaden, Tyskland, 65189
- Ikke rekrutterer endnu
- St. Josefs-Hospital Wiesbaden Gmbh
-
Würzburg, Tyskland, 97080
- Ikke rekrutterer endnu
- Universitaetsklinikum Wuerzburg
-
-
-
-
-
Sankt Pölten, Østrig, 3100
- Ikke rekrutterer endnu
- University Hospital St. Poelten
-
-
State of Vienna
-
Vienna, State of Vienna, Østrig, 1090
- Ikke rekrutterer endnu
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
-
-
Styria
-
Graz, Styria, Østrig, 8036
- Ikke rekrutterer endnu
- Medizinische Universitaetsklinik Graz
-
-
Tyrol
-
Innsbruck, Tyrol, Østrig, 6020
- Ikke rekrutterer endnu
- Medical University Innsbruck
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Elafibranor 120 mg
Participants will take 1 tablet of elafibranor 120 mg orally once daily |
Round and orange film coated tablet of 120 mg
Andre navne:
|
|
Placebo komparator: Placebo
Participants will take 1 placebo tablet orally once daily |
Round and orange film coated tablet of placebo |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-Free Survival
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der udvikler kolangiokarcinom (CCA), hepatocellulært karcinom (HCC) eller kolorektal cancer (CRC)
Tidsramme: Fra baseline indtil behandlingens afslutning (anslået op til 5 år)
|
Fra baseline indtil behandlingens afslutning (anslået op til 5 år)
|
|
|
Percentage of participants with ALP level within the pre-defined level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Ipsen Medical Director, Ipsen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. maj 2026
Primær færdiggørelse (Anslået)
30. april 2031
Studieafslutning (Anslået)
31. maj 2031
Datoer for studieregistrering
Først indsendt
28. januar 2026
Først indsendt, der opfyldte QC-kriterier
28. januar 2026
Først opslået (Faktiske)
4. februar 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLIN-60190-475
- 2026-525242-29-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .