New drug trial offers hope for liver disease patients
NCT ID NCT04526665
Summary
This study is testing a drug called elafibranor for adults with primary biliary cholangitis (PBC), a serious liver disease, who don't get enough benefit from the standard medication. The main goal is to see if the drug improves key liver blood tests and reduces symptoms like severe itching and fatigue. The trial has two parts: a year-long comparison against a placebo, followed by a long-term extension where all participants receive the study drug.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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ASST Monza - Ospedale San Gerardo, Gastroenterologia
Monza, 20900, Italy
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American Research Corporation
San Antonio, Texas, 78215, United States
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Antwerp University Hospital
Edegem, 2650, Belgium
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Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia
Padua, 35128, Italy
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Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia
Milan, 20142, Italy
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Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica
Palermo, 90127, Italy
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Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
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Belfast Health and Social Care Trust-Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
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Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
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CHU Amiens Picardie
Amiens, 80054, France
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CHU Grenoble Alpes - Hôpital Albert Michallon
Grenoble, 38043, France
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California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, 94109, United States
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Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
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Carolinas Centre for Liver disease/ Atrium Health
Huntersville, North Carolina, 28078, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Center for Gastroenterology and Hepatology (GHZ) Kiel
Kiel, 24146, Germany
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Centre Hospitalier Régional d'Orléans
Orléans, 45067, France
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Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
Montreal, H2X 0A9, Canada
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Centro de Investigacion Clinica Universidad Catolica CICUC
Santiago, 8330034, Chile
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Centro de Investigaciones Clinicas (CIC)
Viña del Mar, Región de Valparaíso, 2540364, Chile
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Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik
Berlin, 13353, Germany
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Clínica Universidad de los Andes
Santiago, 7550000, Chile
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Columbia University Medical Center - Center for Liver Disease and Transplantation
New York, New York, 10032, United States
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Complexo Hospitalario Universitario de Pontevedra
Pontevedra, 36071, Spain
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Consultants for Clinical Research
Cincinnati, Ohio, 45249, United States
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Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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EUGASTRO GmbH
Leipzig, 04103, Germany
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Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Bornova, 35100, Turkey (Türkiye)
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Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256, United States
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Fondazione Epatocentro Ticino
Lugano, 6900, Switzerland
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Frimley Health NHS Foundation Trust - Frimley Park Hospital
Camberley, GU16 7UJ, United Kingdom
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Gastro - Sudien
Berlin, 10825, Germany
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Gastro health & Nutrition-Victoria
Victoria, Texas, 77904, United States
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Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
Vancouver, British Columbia, V5Z IM9, Canada
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Groote Schuur Hospital, University of Cape Town - Clinical Research Centre
Cape Town, Western Cap, 7925, South Africa
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Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.
Ankara, 06230, Turkey (Türkiye)
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Henry Ford Health System
Novi, Michigan, 48377, United States
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Hospital Alemán
Caba, Buenos Aires, C1118AAT, Argentina
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Hospital Británico de Buenos Aires
CABA, Buenos Aires, C1280AEB, Argentina
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Hospital Clinic de Barcelona
Barcelona, 08036, Spain
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Hospital Clínico Universidad de Chile
Santiago, 8320000, Chile
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Hospital Espanol De Mendoza
Godoy Cruz, Mendoza Province, 5547, Argentina
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Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
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Hospital Italiano de Buenos Aires
CABA, Buenos Aires, 1199, Argentina
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Hospital Italiano de La Plata
La Plata, Buenos Aires, 1900, Argentina
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Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
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Hospital Universitario Donostia
San Sebastián, 20014, Spain
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Hospital Universitario La Paz
Madrid, 28046, Spain
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Hospital Universitario Marqués de Valdecilla
Santander, 39010, Spain
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Hospital Universitario Puerta de Hierro -Madrid
Madrid, C.P 28222, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
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Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
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Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
São Paulo, São Paulo, 05403-000, Brazil
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Hospital de La Serena
La Serena, Coquimbo Region, 1700000, Chile
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Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary
Hull, HU32J, United Kingdom
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Hôpital Cochin
Paris, 75014, France
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Hôpital Erasme
Brussels, 1070, Belgium
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Hôpital Haut Lévêque
Pessac, 33604, France
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Hôpital Henri Mondor
Créteil, 94000, France
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Hôpital Pitié-Salpétrière
Paris, 75651, France
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Hôpital Robert Debré - CHU de Reims
Reims, 51092, France
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Hôpital Saint-Antoine
Paris, 75012, France
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Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200, France
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Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie
Bern, 3010, Switzerland
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Intermountain Medical Center - Transplant Services
Murray, Utah, 84107, United States
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Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Keck Medical Center of USC
Los Angeles, California, 90033, United States
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King's College Hospital. King's College NHS Foundation Trust
London, SE5 9RS, United Kingdom
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Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
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Liver Center of Texas, PLLC
Dallas, Texas, 75234, United States
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Liver Institute Northwest
Seattle, Washington, 98105, United States
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Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali
Istanbul, Pendik, 34890, Turkey (Türkiye)
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Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical University of South Carolina- College of Medicine
Charleston, South Carolina, 29425, United States
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Mediclinic Constantiaberg, North Suites
Cape Town, 7800, South Africa
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Medizinische Hochschule Hannover
Hanover, 30625, Germany
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NYU Langone Health / NYU Grossman School of Medicine
New York, New York, 10016, United States
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Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
Nottingham, NG72UH, United Kingdom
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Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale
Modena, Località Baggiovara, 41126, Italy
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Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
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Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
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Ruane Clinical Research Group Inc.
Los Angeles, California, 90036, United States
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Saint Louis University
St Louis, Missouri, 63104, United States
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Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
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Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre
Winnipeg, Manitoba, R3E 3P4, Canada
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South Denver Gastroenterology, P.C.
Englewood, Colorado, 80113, United States
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St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research
Houston, Texas, 77030, United States
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Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
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Texas Digestive Disease Consultants dba GI Alliance
Fort Worth, Texas, 76104, United States
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The Institute for Liver Health
Chandler, Arizona, 85224, United States
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The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
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The New York-Presbyterian Hospital, David H. Koch Center
New York, New York, 10065, United States
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The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital
Newcastle upon Tyne, Newcastle, NE7 7DN, United Kingdom
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240, United States
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The University of Texas Southwestern Medical Center-IDS Aston Pharmacy
Dallas, Texas, 75390-8575, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Tiervlei Trial Centre
Cape Town, Western Cape, 7530, South Africa
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UPMC Center for Liver Diseases
New Hyde Park, New York, 11042-11114, United States
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Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
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University Hospital Leuven
Leuven, 3000, Belgium
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
Calgary, Alberta, T2N 4Z6, Canada
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University of California, Davis Medical Center
Sacramento, California, 95817, United States
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University of Colorado Denver and Hospital
Aurora, Colorado, 840045, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition
Salt Lake City, Utah, 84132, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
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Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
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Vanderbilt Digestive Disease Center
Nashville, Tennessee, 37232, United States
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Virginia Commonwealth University Clinical Research Services Unit (CRSU)
Richmond, Virginia, 23298, United States
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Yale School of Medicine, Digestive Diseases
New Haven, Connecticut, 06510, United States
Conditions
Explore the condition pages connected to this study.