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

Locations

  • ASST Monza - Ospedale San Gerardo, Gastroenterologia

    Monza, 20900, Italy

  • American Research Corporation

    San Antonio, Texas, 78215, United States

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia

    Padua, 35128, Italy

  • Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia

    Milan, 20142, Italy

  • Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica

    Palermo, 90127, Italy

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Belfast Health and Social Care Trust-Royal Victoria Hospital

    Belfast, BT12 6BA, United Kingdom

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215, United States

  • CHU Amiens Picardie

    Amiens, 80054, France

  • CHU Grenoble Alpes - Hôpital Albert Michallon

    Grenoble, 38043, France

  • California Pacific Medical Center - Sutter Pacific Medical Foundation

    San Francisco, California, 94109, United States

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Carolinas Centre for Liver disease/ Atrium Health

    Huntersville, North Carolina, 28078, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Center for Gastroenterology and Hepatology (GHZ) Kiel

    Kiel, 24146, Germany

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45067, France

  • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)

    Montreal, H2X 0A9, Canada

  • Centro de Investigacion Clinica Universidad Catolica CICUC

    Santiago, 8330034, Chile

  • Centro de Investigaciones Clinicas (CIC)

    Viña del Mar, Región de Valparaíso, 2540364, Chile

  • Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik

    Berlin, 13353, Germany

  • Clínica Universidad de los Andes

    Santiago, 7550000, Chile

  • Columbia University Medical Center - Center for Liver Disease and Transplantation

    New York, New York, 10032, United States

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra, 36071, Spain

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249, United States

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • EUGASTRO GmbH

    Leipzig, 04103, Germany

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, Bornova, 35100, Turkey (Türkiye)

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256, United States

  • Fondazione Epatocentro Ticino

    Lugano, 6900, Switzerland

  • Frimley Health NHS Foundation Trust - Frimley Park Hospital

    Camberley, GU16 7UJ, United Kingdom

  • Gastro - Sudien

    Berlin, 10825, Germany

  • Gastro health & Nutrition-Victoria

    Victoria, Texas, 77904, United States

  • Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology

    Vancouver, British Columbia, V5Z IM9, Canada

  • Groote Schuur Hospital, University of Cape Town - Clinical Research Centre

    Cape Town, Western Cap, 7925, South Africa

  • Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.

    Ankara, 06230, Turkey (Türkiye)

  • Henry Ford Health System

    Novi, Michigan, 48377, United States

  • Hospital Alemán

    Caba, Buenos Aires, C1118AAT, Argentina

  • Hospital Británico de Buenos Aires

    CABA, Buenos Aires, C1280AEB, Argentina

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universidad de Chile

    Santiago, 8320000, Chile

  • Hospital Espanol De Mendoza

    Godoy Cruz, Mendoza Province, 5547, Argentina

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Italiano de Buenos Aires

    CABA, Buenos Aires, 1199, Argentina

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900, Argentina

  • Hospital Provincial del Centenario

    Rosario, Santa Fe Province, S2002KDS, Argentina

  • Hospital Universitario Donostia

    San Sebastián, 20014, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39010, Spain

  • Hospital Universitario Puerta de Hierro -Madrid

    Madrid, C.P 28222, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de La Serena

    La Serena, Coquimbo Region, 1700000, Chile

  • Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary

    Hull, HU32J, United Kingdom

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Hôpital Haut Lévêque

    Pessac, 33604, France

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Hôpital Pitié-Salpétrière

    Paris, 75651, France

  • Hôpital Robert Debré - CHU de Reims

    Reims, 51092, France

  • Hôpital Saint-Antoine

    Paris, 75012, France

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200, France

  • Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie

    Bern, 3010, Switzerland

  • Intermountain Medical Center - Transplant Services

    Murray, Utah, 84107, United States

  • Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • King's College Hospital. King's College NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030, United States

  • Liver Center of Texas, PLLC

    Dallas, Texas, 75234, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali

    Istanbul, Pendik, 34890, Turkey (Türkiye)

  • Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23602, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina- College of Medicine

    Charleston, South Carolina, 29425, United States

  • Mediclinic Constantiaberg, North Suites

    Cape Town, 7800, South Africa

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • NYU Langone Health / NYU Grossman School of Medicine

    New York, New York, 10016, United States

  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)

    Nottingham, NG72UH, United Kingdom

  • Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale

    Modena, Località Baggiovara, 41126, Italy

  • Plymouth Hospitals NHS Trust, Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226, United States

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036, United States

  • Saint Louis University

    St Louis, Missouri, 63104, United States

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136, United States

  • Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre

    Winnipeg, Manitoba, R3E 3P4, Canada

  • South Denver Gastroenterology, P.C.

    Englewood, Colorado, 80113, United States

  • St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research

    Houston, Texas, 77030, United States

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012, United States

  • Texas Digestive Disease Consultants dba GI Alliance

    Fort Worth, Texas, 76104, United States

  • The Institute for Liver Health

    Chandler, Arizona, 85224, United States

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • The New York-Presbyterian Hospital, David H. Koch Center

    New York, New York, 10065, United States

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital

    Newcastle upon Tyne, Newcastle, NE7 7DN, United Kingdom

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240, United States

  • The University of Texas Southwestern Medical Center-IDS Aston Pharmacy

    Dallas, Texas, 75390-8575, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tiervlei Trial Centre

    Cape Town, Western Cape, 7530, South Africa

  • UPMC Center for Liver Diseases

    New Hyde Park, New York, 11042-11114, United States

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University Hospital Leuven

    Leuven, 3000, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

    Calgary, Alberta, T2N 4Z6, Canada

  • University of California, Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 840045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition

    Salt Lake City, Utah, 84132, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University Clinical Research Services Unit (CRSU)

    Richmond, Virginia, 23298, United States

  • Yale School of Medicine, Digestive Diseases

    New Haven, Connecticut, 06510, United States

Conditions

Explore the condition pages connected to this study.