Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

September 24, 2020

Primary Completion Date

June 1, 2023

Study Completion Date

December 1, 2028

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

Elafibranor 80mg

Elafibranor 80mg daily

DRUG

Placebo

Placebo daily

Trial Locations (115)

1070

Hôpital Erasme, Brussels

1199

Hospital Italiano de Buenos Aires, CABA

1900

Hospital Italiano de La Plata, La Plata

2650

Antwerp University Hospital, Edegem

3000

University Hospital Leuven, Leuven

3010

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

5547

Hospital Espanol De Mendoza, Godoy Cruz

6900

Fondazione Epatocentro Ticino, Lugano

7530

Tiervlei Trial Centre, Cape Town

7800

Mediclinic Constantiaberg, North Suites, Cape Town

7925

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

9000

Universitair Ziekenhuis Gent, Ghent

10016

NYU Langone Health / NYU Grossman School of Medicine, New York

10032

Columbia University Medical Center - Center for Liver Disease and Transplantation, New York

10065

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

10825

Gastro - Sudien, Berlin

13353

Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik, Berlin

17033

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

19107

Thomas Jefferson University, Philadelphia

20014

Hospital Universitario Donostia, San Sebastián

20142

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

20900

ASST Monza - Ospedale San Gerardo, Gastroenterologia, Monza

22908

University of Virginia Medical Center, Charlottesville

23226

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

23298

Virginia Commonwealth University Clinical Research Services Unit (CRSU), Richmond

23602

Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads, Newport News

24146

Center for Gastroenterology and Hepatology (GHZ) Kiel, Kiel

27710

Duke University Medical Center, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28046

Hospital Universitario La Paz, Madrid

28078

Carolinas Centre for Liver disease/ Atrium Health, Huntersville

29425

Medical University of South Carolina- College of Medicine, Charleston

30309

Digestive Healthcare of Georgia, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32256

Encore Borland-Groover Clinical Research, Jacksonville

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33604

Hôpital Haut Lévêque, Pessac

34890

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

35100

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

35128

Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia, Padua

36071

Complexo Hospitalario Universitario de Pontevedra, Pontevedra

37232

Vanderbilt Digestive Disease Center, Nashville

38043

CHU Grenoble Alpes - Hôpital Albert Michallon, Grenoble

39010

Hospital Universitario Marqués de Valdecilla, Santander

40138

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

41013

Hospital Universitario Virgen del Rocio, Seville

41126

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

44106

University Hospitals Cleveland Medical Center, Cleveland

45067

Centre Hospitalier Régional d'Orléans, Orléans

45249

Consultants for Clinical Research, Cincinnati

48377

Henry Ford Health System, Novi

51092

Hôpital Robert Debré - CHU de Reims, Reims

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60590

Universitätsklinikum Frankfurt, Frankfurt

63104

Saint Louis University, St Louis

66160

University of Kansas Medical Center, Kansas City

67200

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre, Strasbourg

75012

Hôpital Saint-Antoine, Paris

75014

Hôpital Cochin, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75234

Liver Center of Texas, PLLC, Dallas

75651

Hôpital Pitié-Salpétrière, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

76104

Texas Digestive Disease Consultants dba GI Alliance, Fort Worth

77030

Liver Associates of Texas, P.A., Houston

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

77904

Gastro health & Nutrition-Victoria, Victoria

78215

American Research Corporation, San Antonio

80054

CHU Amiens Picardie, Amiens

80113

South Denver Gastroenterology, P.C., Englewood

84107

Intermountain Medical Center - Transplant Services, Murray

84132

University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition, Salt Lake City

85224

The Institute for Liver Health, Chandler

90033

Keck Medical Center of USC, Los Angeles

90036

Ruane Clinical Research Group Inc., Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90127

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

94000

Hôpital Henri Mondor, Créteil

94109

California Pacific Medical Center - Sutter Pacific Medical Foundation, San Francisco

95817

University of California, Davis Medical Center, Sacramento

98105

Liver Institute Northwest, Seattle

840045

University of Colorado Denver and Hospital, Aurora

1700000

Hospital de La Serena, La Serena

2540364

Centro de Investigaciones Clinicas (CIC), Viña del Mar

7550000

Clínica Universidad de los Andes, Santiago

8320000

Hospital Clínico Universidad de Chile, Santiago

8330034

Centro de Investigacion Clinica Universidad Catolica CICUC, Santiago

06510

Yale School of Medicine, Digestive Diseases, New Haven

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center (BIDMC), Boston

11042-11114

UPMC Center for Liver Diseases, New Hyde Park

43210-1240

The Ohio State University Wexner Medical Center, Columbus

75390-8575

The University of Texas Southwestern Medical Center-IDS Aston Pharmacy, Dallas

C1118AAT

Hospital Alemán, Caba

C1280AEB

Hospital Británico de Buenos Aires, CABA

S2002KDS

Hospital Provincial del Centenario, Rosario

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

05403-000

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

T2N 4Z6

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

V5Z IM9

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

R3E 3P4

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

H2X 0A9

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

04103

EUGASTRO GmbH, Leipzig

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

C.P 28222

Hospital Universitario Puerta de Hierro -Madrid, Madrid

06230

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

NE7 7DN

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

BT12 6BA

Belfast Health and Social Care Trust-Royal Victoria Hospital, Belfast

GU16 7UJ

Frimley Health NHS Foundation Trust - Frimley Park Hospital, Camberley

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge

HU32J

Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary, Hull

SE5 9RS

King's College Hospital. King's College NHS Foundation Trust, London

NG72UH

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

PL6 8DH

Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY