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一项评估Elafibranor在成年原发性硬化性胆管炎患者中疗效与安全性的研究 (ELASCOPE)

2026年10月20日更新者：Ipsen

一项评估Elafibranor在成人原发性硬化性胆管炎患者中的疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究

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.

研究概览

地位

招聘中

条件

原发性硬化性胆管炎

干预/治疗

研究类型

介入性

注册 (估计的)

350

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Ipsen Clinical Study Enquiries
电话号码：see email
邮箱：clinical.trials@ipsen.com

学习地点

中国
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100032
    - 尚未招聘
    - Peking Union Medical College Hospital
  - Beijing、Beijing Municipality、中国、100050
    - 尚未招聘
    - Beijing Friendship Hospital, Capital Medical University
  - Beijing、Beijing Municipality、中国、100015
    - 尚未招聘
    - Beijing Ditan Hospital
  - Beijing、Beijing Municipality、中国、100044
    - 尚未招聘
    - Peking University Peoples Hospital (PKUPH)
- Guangdong
  - Guangzhou、Guangdong、中国、510060
    - 尚未招聘
    - Guangzhou Eighth People's Hospital
- Henan
  - Zhengzhou、Henan、中国、450003
    - 尚未招聘
    - Henan Provincial People's Hospital
- Jiangxi
  - Nanchang、Jiangxi、中国、330000
    - 尚未招聘
    - The Second Affiliated Hospital Of Nanchang University
- Jilin
  - Changchun、Jilin、中国、130021
    - 尚未招聘
    - The First Hospital of Jilin University
- Shandong
  - Jinan、Shandong、中国、250012
    - 尚未招聘
    - Qilu Hospital of Shandong University
- Shanghai Municipality
  - Shanghai、Shanghai Municipality、中国、200001
    - 招聘中
    - Renji hospital shanghai jiao tong university school of medicine
- Tianjin Municipality
  - Tianjin、Tianjin Municipality、中国、300052
    - 尚未招聘
    - Tianjin Medical University General Hospital
丹麦
- - Aarhus、丹麦、8200
    - 尚未招聘
    - Aarhus Universitets hospital
- Capital Region
  - Copenhagen、Capital Region、丹麦、2100
    - 尚未招聘
    - Copenhagen University Hospital-Rigshospitalet University Hospital
加拿大
- Alberta
  - Calgary、Alberta、加拿大、T2N 4Z6
    - 尚未招聘
    - University of Calgary
  - Edmonton、Alberta、加拿大、T6G 2X8
    - 尚未招聘
    - University Of Alberta Hospital-Zeidler Ledcor Centre
- British Columbia
  - Vancouver、British Columbia、加拿大、V6Z 2K5
    - 尚未招聘
    - (G.I.R.I) GI Research Institute Foundation
- Manitoba
  - Winnipeg、Manitoba、加拿大、R3E 3P4
    - 尚未招聘
    - Shared Health Inc. Health Sciences Centre
- New Brunswick
  - Halifax、New Brunswick、加拿大、B3H2Y9
    - 尚未招聘
    - Queen Elizabeth II (QEII) Health Sciences Centre -Dalhousie University-Victoria General
- Ontario
  - Brampton、Ontario、加拿大、L6R 3J7
    - 尚未招聘
    - Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
  - London、Ontario、加拿大、N6A 5A5
    - 尚未招聘
    - London Health Sciences Centre (LHSC) - University Hospital
  - North Bay、Ontario、加拿大、P1B 2H3
    - 尚未招聘
    - Dr Gauthier,MD,Office Of
  - Ottawa、Ontario、加拿大、K1H 8L6
    - 尚未招聘
    - The Ottawa Hospital - General Campus
  - Toronto、Ontario、加拿大、M5G 2C4
    - 尚未招聘
    - University Health Network (UHN) - Toronto General Hospital (TGH) - Liver Transplant Clinic
  - Toronto、Ontario、加拿大、M6H 3M1
    - 尚未招聘
    - Toronto Liver Centre
- Quebec
  - Montreal、Quebec、加拿大、H2X 0A9
    - 尚未招聘
    - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
奥地利
- - Sankt Pölten、奥地利、3100
    - 尚未招聘
    - University Hospital St. Poelten
- State of Vienna
  - Vienna、State of Vienna、奥地利、1090
    - 尚未招聘
    - Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
- Styria
  - Graz、Styria、奥地利、8036
    - 尚未招聘
    - Medizinische Universitaetsklinik Graz
- Tyrol
  - Innsbruck、Tyrol、奥地利、6020
    - 尚未招聘
    - Medical University Innsbruck
巴西
- - Brasília、巴西、70335 900
    - 尚未招聘
    - Instituto de Gestao Estrategica de Saude do Distrito Federal
  - Rio de Janeiro、巴西、22793-334
    - 尚未招聘
    - Instituto Americas
- Espírito Santo
  - Vitória、Espírito Santo、巴西、29040-091
    - 尚未招聘
    - Hospital Universitario Cassiano Antonio de Moraes
  - Vitória、Espírito Santo、巴西、29040-091
    - 尚未招聘
    - Hospital Universitario Cassiano
- Estado de Bahia
  - Salvador、Estado de Bahia、巴西、41920-900
    - 尚未招聘
    - Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
- Goiás
  - Goiânia、Goiás、巴西、74605
    - 尚未招聘
    - Hospital das Clínicas da Universidade Federal de Goias - HC-UFG
- Minas Gerais
  - Belo Horizonte、Minas Gerais、巴西、30140-062
    - 尚未招聘
    - Nucleo de Pesquisa Clinica NUPEC
- Rio Grande do Sul
  - Porto Alegre、Rio Grande do Sul、巴西、90035-903
    - 尚未招聘
    - Hospital de Clinicas de Porto Alegre (HCPA)
- Rio de Janeiro
  - Rio de Janeiro、Rio de Janeiro、巴西、21941-617
    - 尚未招聘
    - Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
- SaoPaulo
  - Botucatu、SaoPaulo、巴西、18618970
    - 尚未招聘
    - Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
- São Paulo
  - São José do Rio Preto、São Paulo、巴西、15090-000
    - 尚未招聘
    - Hospital de Base - Centro Integrado de Pesquisa ( CIP )
  - São Paulo、São Paulo、巴西、05403-000
    - 尚未招聘
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
德国
- - Berlin、德国、13359
    - 尚未招聘
    - DRK Kliniken Berlin Mitte
  - Dresden、德国、1307
    - 尚未招聘
    - Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
  - Hanover、德国、30625
    - 尚未招聘
    - Medizinische Hochschule Hannover, Hannover Medical School
  - Heidelberg、德国、69120
    - 尚未招聘
    - Universitatsklinikum Heidelberg
  - Leipzig、德国、4103
    - 尚未招聘
    - Universitaetsklinikum Leipzig
  - Magdeburg、德国、39120
    - 尚未招聘
    - Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetshautklinik
  - Mainz、德国、55131
    - 尚未招聘
    - Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
  - Tübingen、德国、72076
    - 尚未招聘
    - Universitaetsklinikum Tuebingen
  - Wiesbaden、德国、65189
    - 尚未招聘
    - St. Josefs-Hospital Wiesbaden Gmbh
  - Würzburg、德国、97080
    - 尚未招聘
    - Universitaetsklinikum Wuerzburg
意大利
- - Genova、意大利、16132
    - 尚未招聘
    - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
  - Milan、意大利、20162
    - 尚未招聘
    - ASST Grande Ospedale Metropolitano Niguarda
  - Modena、意大利、41124
    - 尚未招聘
    - Azienda Ospedaliero-Universitaria Policlinico di Modena
  - Monza、意大利、20900
    - 尚未招聘
    - Ospedale San Gerardo
  - Novara、意大利、28100
    - 尚未招聘
    - Azienda Ospedaliero Universitaria Maggiore della Carità
  - Padova、意大利、35128
    - 尚未招聘
    - Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
  - Roma、意大利、168
    - 尚未招聘
    - A. Gemelli University Hospital, Catholic University of the Sacred Heart
  - Rozzano、意大利、20089
    - 尚未招聘
    - IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
  - Udine、意大利、33100
    - 尚未招聘
    - ASUFC
挪威
- - Bergen、挪威、5009
    - 尚未招聘
    - Haraldsplass Diakonale Sykehus
  - Oslo、挪威、372
    - 招聘中
    - Oslo University Hospital
- Akershus
  - Lorenskog、Akershus、挪威、1478
    - 尚未招聘
    - Akershus Universitetssykehus HF
捷克语
- - Pilsen、捷克语、301 00
    - 尚未招聘
    - Research Site s.r.o.
  - Prague、捷克语、14021
    - 尚未招聘
    - Institute for Clinical and Experimental Medicine - IKEM
  - Prague、捷克语、190 00
    - 招聘中
    - ISCARE IVF Klinika Centrum
日本
- - Tokyo、日本、160-8582
    - 尚未招聘
    - Keio University Hospital
- Chiba
  - Chiba、Chiba、日本、260-8677
    - 尚未招聘
    - Chiba University Hospital
- Hiroshima
  - Hiroshima、Hiroshima、日本、734-8551
    - 尚未招聘
    - Hiroshima University Hospital
- Itabashi-ku
  - tabashi City、Itabashi-ku、日本、173-8606
    - 尚未招聘
    - Teikyo University Hospital
- Kanagawa
  - Yokohama、Kanagawa、日本、232-0024
    - 尚未招聘
    - Yokohama City University Medical Center
- Nagasaki
  - Ōmura、Nagasaki、日本、856-8562
    - 尚未招聘
    - National Hospital Organization Nagasaki Medical Center
- Nara
  - Kashihara、Nara、日本、634-8522
    - 尚未招聘
    - Nara Medical University Hospital
- Niigata
  - Niigata、Niigata、日本、951-8520
    - 尚未招聘
    - Niigata University Medical & Dental Hospital
- Osaka
  - Suita、Osaka、日本、565-0871
    - 尚未招聘
    - The University of Osaka Hospital
- Tokyo
  - Bunkyo-ku、Tokyo、日本、113-8431
    - 尚未招聘
    - Juntendo University Hospital
  - Bunkyo-ku、Tokyo、日本、113-8655
    - 尚未招聘
    - The University of Tokyo Hospital
比利时
- - Edegem、比利时、2650
    - 尚未招聘
    - Universitair Ziekenhuis Antwerpen
  - Ghent、比利时、9000
    - 招聘中
    - UZ Gent
  - Leuven、比利时、3000
    - 招聘中
    - Universitair Ziekenhuis Leuven
- Anderlecht
  - Brussels、Anderlecht、比利时、1070
    - 招聘中
    - Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
- Brussels Capital
  - Woluwe-Saint-Lambert、Brussels Capital、比利时、1200
    - 尚未招聘
    - Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
法国
- - Lille、法国、59000
    - 尚未招聘
    - Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
  - Lyon、法国、69004
    - 尚未招聘
    - Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
  - Montpellier、法国、34295
    - 尚未招聘
    - Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
  - Nantes、法国、44093
    - 招聘中
    - Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
  - Paris、法国、75012
    - 招聘中
    - Hopitaux Universitaires Est Parisien - Hopital Saint-Antoine
  - Paris、法国、75013
    - 尚未招聘
    - Hopitaux Universitaires Pitie Salpetriere Charles Foix
  - Toulouse、法国、31076
    - 尚未招聘
    - Clinique Pasteur
  - Villejuif、法国、94800
    - 招聘中
    - Centre Hepato-Biliaire Hospital Paul Brousse (AP-HP)
波兰
- - Lublin、波兰、20-582
    - 尚未招聘
    - Medrise sp. z o.o
  - Mysłowice、波兰、41-400
    - 招聘中
    - ID Clinic
  - Warsaw、波兰、04-501
    - 招聘中
    - Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
澳大利亚
- - Epping、澳大利亚、3076
    - 尚未招聘
    - Northern Hospital Epping
  - Fitzroy、澳大利亚、3065
    - 招聘中
    - St Vincent's Hospital
- New South Wales
  - Saint Leonards、New South Wales、澳大利亚、2065
    - 尚未招聘
    - Royal North Shore Hospital
  - Westmead、New South Wales、澳大利亚、2145
    - 尚未招聘
    - Westmead Hospital
- Queensland
  - Birtinya、Queensland、澳大利亚、4575
    - 尚未招聘
    - Sunshine Coast University Hospital
  - South Brisbane、Queensland、澳大利亚、v
    - 尚未招聘
    - Mater Hospital Brisbane
- South Australia
  - Adelaide、South Australia、澳大利亚、5112
    - 尚未招聘
    - Lyell McEwin Hospital
  - Adelaide、South Australia、澳大利亚、5000
    - 尚未招聘
    - Central Adelaide Local Health Network - Royal Adelaide Hospital
- Victoria
  - Heidelberg、Victoria、澳大利亚、3084
    - 尚未招聘
    - Austin Hospital
  - Melbourne、Victoria、澳大利亚、3004
    - 尚未招聘
    - The Alfred Hospital
- Western Australia
  - Nedlands、Western Australia、澳大利亚、6009
    - 尚未招聘
    - Sir Charles Gairdner Hospital (SCGH)
瑞典
- - Gothenburg、瑞典、413 45
    - 尚未招聘
    - Mag-Tarm Mottagningen-Sahlgrenska Universitetssjukhuset
  - Stockholm、瑞典、141 86
    - 尚未招聘
    - Karolinska Universitetssjukhuset
  - Uppsala、瑞典、751 85
    - 尚未招聘
    - Akademiska Sjukhuset - Uppsala University Hospital
  - Örebro、瑞典、702 21
    - 尚未招聘
    - Orebro University Hospital
瑞士
- - Basel、瑞士、4031
    - 尚未招聘
    - University Hospital Basel
  - Bern、瑞士、3010
    - 尚未招聘
    - Universitaetsspital Bern - Inselspital
  - Lugano、瑞士、6900
    - 尚未招聘
    - Ospedale Civico
  - Zurich、瑞士、8091
    - 尚未招聘
    - Universitatsspital Zurich
罗马尼亚
- - Bucharest、罗马尼亚、20475
    - 招聘中
    - Spital Clinic Dr I Cantacuzino
  - Bucharest、罗马尼亚、22328
    - 尚未招聘
    - Institutul Clinic Fundeni
  - Iași、罗马尼亚、700111
    - 招聘中
    - Gastromedica Srl
- Jud Satu-Mare
  - Satu Mare、Jud Satu-Mare、罗马尼亚
    - 招聘中
    - Spitalul Judetean de Urgenta Satu Mare
- Jud. Cluj
  - Cluj-Napoca、Jud. Cluj、罗马尼亚、400132
    - 招聘中
    - Spitalul Clinic De Urgenta Prof. Dr. Octavian Fodor
美国
- Arizona
  - Chandler、Arizona、美国、85224
    - 招聘中
    - Arizona Liver Health
  - Phoenix、Arizona、美国、85054
    - 尚未招聘
    - Mayo Clinic in Arizona
- California
  - Coronado、California、美国、92118
    - 招聘中
    - Southern California Research Center
  - La Jolla、California、美国、92037-0897
    - 尚未招聘
    - University of California San Diego
  - Los Angeles、California、美国、90048
    - 尚未招聘
    - Cedars-Sinai Medical Center
  - Los Angeles、California、美国、90033
    - 尚未招聘
    - Keck Medicine of USC - USC Healthcare Center 1
  - Pasadena、California、美国、91105
    - 招聘中
    - California Liver Research Institute
  - Redwood City、California、美国、94063
    - 尚未招聘
    - Stanford University
  - Sacramento、California、美国、95817
    - 尚未招聘
    - University of California Davis Medical Center
  - San Francisco、California、美国、94143
    - 招聘中
    - University of California, San Francisco Medical Center
  - San Francisco、California、美国、94109
    - 尚未招聘
    - Sutter Health Van Ness Campus Medical Office Building
- Colorado
  - Aurora、Colorado、美国、80045
    - 尚未招聘
    - University of Colorado Hospital Anschutz Outpatient Pavilion
  - Colorado Springs、Colorado、美国、80920
    - 招聘中
    - Peak Gastroenterology Associates
  - Englewood、Colorado、美国、80113
    - 招聘中
    - South Denver Gastroenterology,P.C.
  - Littleton、Colorado、美国、90046
    - 招聘中
    - Rocky Mountain Gastroenterology (RMG)
- Connecticut
  - New Haven、Connecticut、美国、06510-2738
    - 尚未招聘
    - Yale Medical Group - Yale Digestive Diseases -Temple Medical Center Location
- District of Columbia
  - Washington D.C.、District of Columbia、美国、20007
    - 尚未招聘
    - MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
- Florida
  - Miami、Florida、美国、33136
    - 招聘中
    - University of Miami - Schiff Center for Liver Diseases
- Georgia
  - Atlanta、Georgia、美国、30309
    - 尚未招聘
    - Piedmont Hospital - Piedmont Transplant Institute
- Illinois
  - Chicago、Illinois、美国、60612
    - 尚未招聘
    - Rush University Medical Center
  - Chicago、Illinois、美国、60637
    - 尚未招聘
    - The University of Chicago Medicine
  - Chicago、Illinois、美国、60611
    - 尚未招聘
    - Northwestern Medicine
- Indiana
  - Indianapolis、Indiana、美国、46202
    - 招聘中
    - Indiana University School of Medicine
  - New Albany、Indiana、美国、47150
    - 尚未招聘
    - Gastroenterology Health Partners, PLLC (Southern Indiana Location)
  - Newburgh、Indiana、美国、47630
    - 尚未招聘
    - Deaconess GI Specialty Center
- Iowa
  - Iowa City、Iowa、美国、52242
    - 招聘中
    - The University of Iowa Hospitals & Clinics
- Kentucky
  - Louisville、Kentucky、美国、40202
    - 尚未招聘
    - University Of Louisville School Of Medicine
- Maryland
  - Baltimore、Maryland、美国、21202
    - 招聘中
    - Mercy Medical Center, Inc
  - Baltimore、Maryland、美国、21287
    - 尚未招聘
    - Johns Hopkins University School of Medicine
- Massachusetts
  - Boston、Massachusetts、美国、02114
    - 尚未招聘
    - Massachusetts General Hospital
  - Boston、Massachusetts、美国、02215
    - 尚未招聘
    - Beth Israel Deaconess Medical Center
- Michigan
  - Ann Arbor、Michigan、美国、48109
    - 尚未招聘
    - University of Michigan
  - Detroit、Michigan、美国、48202
    - 尚未招聘
    - Henry Ford Health System
- Minnesota
  - Rochester、Minnesota、美国、55905
    - 尚未招聘
    - Mayo Clinic Cancer Center (MCCC) - Rochester
- Missouri
  - St Louis、Missouri、美国、63104-1015
    - 尚未招聘
    - Saint Louis University
- Nebraska
  - Omaha、Nebraska、美国、68198
    - 尚未招聘
    - University of Nebraska Medical Center
- New York
  - New York、New York、美国、10029
    - 尚未招聘
    - Mount Sinai Medical Center
  - New York、New York、美国、10016
    - 尚未招聘
    - NYU Langone Gastroenterology and Hepatology Associates
  - New York、New York、美国、10021
    - 尚未招聘
    - Weill Medical College Of Cornell University
  - Rochester、New York、美国、14642
    - 尚未招聘
    - University of Rochester Medical Center
- North Carolina
  - Asheville、North Carolina、美国、28803
    - 尚未招聘
    - Digestive Health Partners, PA
  - Chapel Hill、North Carolina、美国、27599-7584
    - 尚未招聘
    - The University of North Carolina at Chapel Hill
  - Charlotte、North Carolina、美国、28204
    - 尚未招聘
    - Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant Centre
  - Durham、North Carolina、美国、27710
    - 尚未招聘
    - Duke University Health System
- Ohio
  - Beavercreek、Ohio、美国、45440
    - 尚未招聘
    - Dayton Gastroenterology- Englewood
  - Cleveland、Ohio、美国、44106
    - 尚未招聘
    - University Hospitals Cleveland Medical Center
  - Cleveland、Ohio、美国、44195-0001
    - 尚未招聘
    - Cleveland Clinic Foundation
- Pennsylvania
  - Hershey、Pennsylvania、美国、17033
    - 尚未招聘
    - Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
  - Philadelphia、Pennsylvania、美国、19104
    - 尚未招聘
    - University of Pennsylvania - Perelman Center for Advanced Medicine
  - Philadelphia、Pennsylvania、美国、19107-5244
    - 尚未招聘
    - Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)
- Rhode Island
  - Providence、Rhode Island、美国、02904
    - 招聘中
    - University Gastroenterology
- South Carolina
  - Charleston、South Carolina、美国、29425
    - 招聘中
    - Medical University of South Carolina (MUSC)
- South Dakota
  - Rapid City、South Dakota、美国、57701
    - 尚未招聘
    - Rapid City Medical Center
- Tennessee
  - Cordova、Tennessee、美国、38018
    - 招聘中
    - Gastro One
  - Johnson City、Tennessee、美国、37604
    - 招聘中
    - Gastrointestinal Associates of Northeast Tennessee
- Texas
  - Dallas、Texas、美国、75390-9045
    - 尚未招聘
    - University of Texas Southwestern Medical Center
  - Dallas、Texas、美国、75203
    - 招聘中
    - Methodist Health Systems Clinical Research Institute
  - Houston、Texas、美国、77030
    - 尚未招聘
    - Houston Methodist Hospital
  - Houston、Texas、美国、77030
    - 招聘中
    - Liver Associates of Texas, P.A.
  - Houston、Texas、美国、77030
    - 尚未招聘
    - Baylor College of Medicine - Advanced Liver Therapies
  - San Antonio、Texas、美国、78215
    - 招聘中
    - American Research Corporation at The Texas Liver Institute
  - San Antonio、Texas、美国、78251
    - 招聘中
    - Starhope Liver Center, PA - Starhope Clinical Research, LLC
- Utah
  - Murray、Utah、美国、84107
    - 尚未招聘
    - Intermountain Medical Center
- Virginia
  - Charlottesville、Virginia、美国、22903
    - 招聘中
    - University of Virginia Medical Center
  - Richmond、Virginia、美国、23226
    - 尚未招聘
    - Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
  - Richmond、Virginia、美国、23298-0341
    - 尚未招聘
    - Virginia Commonwealth University Medical Center
- Washington
  - Bellevue、Washington、美国、98004
    - 尚未招聘
    - Northwest Gastroenterology Associates
  - Seattle、Washington、美国、98105
    - 招聘中
    - Velocity Clinical Research, Seattle
- Wisconsin
  - Madison、Wisconsin、美国、53792
    - 尚未招聘
    - University of Wisconsin Hospitals and Clinics
芬兰
- - Turku、芬兰、20521
    - 尚未招聘
    - Turun Yliopistollinen Keskussairaala (TYKS) - Main Hospital
英国
- - Aberdeen、英国、AB25 2ZD
    - 尚未招聘
    - Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
  - Birmingham、英国、B15 2TT
    - 尚未招聘
    - Queen Elizabeth Hospital
  - Glasgow、英国、G4 0SF
    - 尚未招聘
    - NHS Greater Glasgow and Clyde (NHSGGC), The Queen Elizabeth University Hospital (QEUH)
  - London、英国、E1 1FR
    - 尚未招聘
    - The Royal London Hospital - Barts Health NHS Trust
  - Newcastle upon Tyne、英国、NE7 7DN
    - 尚未招聘
    - Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Camberley
  - Frimley、Camberley、英国、GU16 7UJ
    - 尚未招聘
    - Frimley Park Hospital - Frimley Health NHS Foundation Trust
- Greater London
  - London、Greater London、英国、SE5 9RS
    - 尚未招聘
    - King's College Hospital
  - London、Greater London、英国、NW3 2QG
    - 尚未招聘
    - The Royal Free Hospital - Royal Free London NHS Foundation Trust
- Norfolk
  - Norwich、Norfolk、英国、NR4 7UY
    - 尚未招聘
    - Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
- Oxfordshire
  - Oxford、Oxfordshire、英国、OX3 9DU
    - 尚未招聘
    - John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
- Yorkshire and the Humber
  - Cottingham、Yorkshire and the Humber、英国、HU16 5JQ
    - 尚未招聘
    - Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital - Queen's Centre for Oncology and Haematology
荷兰
- - Amsterdam、荷兰、1081 HV
    - 尚未招聘
    - Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
  - Groningen、荷兰、9713 GZ
    - 尚未招聘
    - University Medical Center Groningen
  - Leiden、荷兰、2333 ZA
    - 尚未招聘
    - Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
  - Rotterdam、荷兰、3015 GD
    - 尚未招聘
    - Erasmus University Medical Center
  - Utrecht、荷兰、3584 CX
    - 尚未招聘
    - Universitair Medisch Centrum Utrecht (UMC Utrecht)
- Gelderland
  - Nijmegen、Gelderland、荷兰、6525 GA
    - 招聘中
    - Radboud University Medical Center
葡萄牙
- - Coimbra、葡萄牙、3000-075
    - 尚未招聘
    - Centro Hospitalar E Universitario de Coimbra EPE
  - Lisbon、葡萄牙、1649-035
    - 尚未招聘
    - Hospital Santa Maria
  - Porto、葡萄牙、4100-180
    - 尚未招聘
    - CUF Porto Hospital
- Lisbon District
  - Lisbon、Lisbon District、葡萄牙、1500-650
    - 尚未招聘
    - Hospital da Luz Lisboa
  - Lisbon、Lisbon District、葡萄牙、1150-199
    - 尚未招聘
    - Unidade Local De Saude De Sao Jose E.P.E.
- Porto District
  - Porto、Porto District、葡萄牙、4050-011
    - 尚未招聘
    - Unidade Local de Saude de Santo Antonio
西班牙
- - Barcelona、西班牙、8036
    - 招聘中
    - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
  - Barcelona、西班牙、8003
    - 尚未招聘
    - Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) (Hospital del Mar Research Institute)
  - Barcelona、西班牙、8035
    - 尚未招聘
    - Vall de Hebron University Hospital
  - Córdoba、西班牙、14004
    - 尚未招聘
    - Hospital Universitario Reina Sofia
  - Madrid、西班牙、28034
    - 招聘中
    - Hospital Universitario Ramon y Cajal
  - Madrid、西班牙、28046
    - 尚未招聘
    - Hospital Universitario La Paz
  - Madrid、西班牙、28007
    - 尚未招聘
    - Hospital General Universitario Gregorio Maranon (HGUGM)
  - Pontevedra、西班牙、36071
    - 尚未招聘
    - Hospital De Montecelo
  - Santander、西班牙、39008
    - 尚未招聘
    - Instituto De Investigacion Marques De Valdecilla (IDIVAL)
  - Valencia、西班牙、46026
    - 招聘中
    - Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
  - Zaragoza、西班牙、50009
    - 尚未招聘
    - Hospital Universitario Miguel Servet de Zaragoza
阿根廷
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷
    - 尚未招聘
    - GEDYT (Gastroenterologia Diagnostica y Terapeutica)
  - San Juan Bautista、Buenos Aires、阿根廷、1888
    - 尚未招聘
    - Hospital El Cruce
- Buenos Aires F.D.
  - Buenos Aires、Buenos Aires F.D.、阿根廷、1181
    - 尚未招聘
    - Hospital Italiano de Buenos Aires
  - Buenos Aires、Buenos Aires F.D.、阿根廷、C1023AAB
    - 尚未招聘
    - STAT Research S.A.
- Pcia de Buenos Aires
  - Pilar、Pcia de Buenos Aires、阿根廷、B16290DT
    - 尚未招聘
    - Hospital Universitario Austral
- Santa Fe Province
  - Santa Fe、Santa Fe Province、阿根廷、S2002KDS
    - 尚未招聘
    - Hospital Provincial del Centenario
韩国
- - Busan、韩国、49241
    - 尚未招聘
    - Pusan National University Hospital (PNUH)
  - Seoul、韩国、Seoul
    - 尚未招聘
    - Samsung Medical Center
  - Seoul、韩国、Seoul
    - 尚未招聘
    - Seoul National University Hospital
- Seoul
  - Seoul、Seoul、韩国、5505
    - 尚未招聘
    - Asan Medical Center (AMC)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Elafibranor 120 mg Participants will take 1 tablet of elafibranor 120 mg orally once daily	药品：Elafibranor Round and orange film coated tablet of 120 mg 其他名称： IPN60190
安慰剂比较：Placebo Participants will take 1 placebo tablet orally once daily	其他：Placebo Round and orange film coated tablet of placebo

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Event-Free Survival 大体时间：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)

次要结果测量

结果测量	措施说明	大体时间
发生胆管癌（CCA）、肝细胞癌（HCC）或结直肠癌（CRC）的参与者百分比大体时间：从基线期至治疗结束（预计最长5年）		从基线期至治疗结束（预计最长5年）
Percentage of participants with ALP level within the pre-defined level 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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 大体时间：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. 大体时间：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) 大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ipsen

调查人员

研究主任：Ipsen Medical Director、Ipsen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月14日

初级完成 (估计的)

2031年4月30日

研究完成 (估计的)

2031年5月31日

研究注册日期

首次提交

2026年1月28日

首先提交符合 QC 标准的

2026年1月28日

首次发布 (实际的)

2026年2月4日

研究记录更新

最后更新发布 (实际的)

2026年10月23日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年10月1日

一项评估Elafibranor在成年原发性硬化性胆管炎患者中疗效与安全性的研究 (ELASCOPE)

一项评估Elafibranor在成人原发性硬化性胆管炎患者中的疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

IPD 共享时间框架

IPD 共享访问标准

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品