Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,157

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

October 28, 2020

Study Completion Date

October 28, 2020

Conditions
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Interventions
DRUG

Elafibranor

DRUG

Placebo

Trial Locations (326)

909

Fundación de Investigación, San Juan

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

1070

Hôpital Erasme, Brussels

1090

Universitair Ziekenhuis Brussel, Brussels

1118

Hospital Alemán, Buenos Aires

1119

Centro de Investigación y Prevención Cardiovascular SA (CIPREC), Buenos Aires

1180

Fundación Sanatorio Güemes, Buenos Aires

1181

Hospital Italiano de Buenos Aires, Buenos Aires

1200

Cliniques Universitaires Saint-Luc, Brussels

1280

Hospital Británico de Buenos Aires, Buenos Aires

1430

CCBR Clinical Research, Buenos Aires

1629

Hospital Universitario Austral, Pilar

1704

Centro De Hepatologia Ciudad de La Plata, La Plata

Dim Clinica Privada, Ramos Mejía

2000

Hospital Provincial del Centenario, Rosario

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2217

The St George Hospital, Kogarah

2650

Universitair Ziekenhuis Antwerpen, Edegem

2747

Nepean Hospital, Kingswood

2900

Instituto de Investigaciones Clinicas San Nicolas SRL, San Nicolás de los Arroyos

3000

Universitair Ziekenhuis Leuven, Leuven

3004

The Alfred Hospital, Melbourne

3010

INSELSPITAL, University Hospital Bern, Bern

3065

St. Vincent's Hospital Melbourne, Fitzroy

3084

Austin Hospital, Heidelberg

3128

Box Hill Hospital, Box Hill

3168

Monash Medical Centre Clayton, Clayton

5042

Flinders Medical Centre, Bedford Park

6001

Phoenix Pharma (Pty) Ltd, Port Elizabeth

6009

Sir Charles Gairdner Hospital (SCGH), Nedlands

6100

Ankara Üniversitesi Tıp Fakültesi, Ankara

6150

Fiona Stanley Hospital, Murdoch

6700

Hospital Angeles Clinica Londres, México

7500

Centre Hospitalier de Wallonie Picardie (CHWAPI), Tournai

7530

Tiervlei Trial Centre, Cape Town

7800

Mediclinic Constantiaberg, Cape Town

8000

Aarhus University Hospital, Aarhus

8025

Hospital de la Santa Creu i Sant Pau, Barcelona

8035

Hospital Universitario Vall d'Hebron, Barcelona

8036

Hospital Clinic i Provincial, Barcelona

8091

UniversitätsSpital Zürich, Zurich

9000

Universitair Ziekenhuis Gent, Ghent

9007

Kantonsspital St. Gallen, Sankt Gallen

10016

Concorde Medical Group, New York

New York University Langone Medical Center, New York

10021

Weill Medical College of Cornell University, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

New York-Presbyterian Hospital - Columbia University Medical Center, New York

10126

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino

10467

Montefiore Medical Center, The Bronx

10969

Liver Center, Berlin

11030

Hofstra Northwell School of Medicine, Manhasset

12601

Premier Medical Group, Poughkeepsie

13285

Hôpital Saint Joseph, Marseille

14050

Médica Sur, Mexico City

14186

Karolinska Universitetssjukhuset Huddinge, Stockholm

14203

University at Buffalo, Clinical and Translational Research Center, Buffalo

15213

UPMC Montefiore, Pittsburgh

19102

Drexel University, College of Medicine, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19140

Temple University Health System, Philadelphia

19141

Albert Einstein Medical Center, Philadelphia

20007

Georgetown University Hospitals, Washington D.C.

20016

Sibley Memorial Hospital, Washington D.C.

20099

Asklepios Klinik St. Georg, Hamburg

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20246

Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg

20850

Kaiser Permanente Shady Grove Medical Center, Rockville

20889

Walter Reed National Military Medical Center, Bethesda

21205

Johns Hopkins Hospital, Baltimore

22042

Inova Fairfax Medical Campus - Center for Liver Disease, Falls Church

22150

Kaiser Permanente Springfield Medical Center, Springfield

22710

Duke Gastroenterology, Durham

22908

University of Virginia Health System, Charlottesville

University of Virginia, Charlottesville

23226

Bon Secours Liver Institute of Virginia - Richmond, Richmond

23249

Hunter Holmes McGuire VA Medical Center, Richmond

23298

Virginia Commonwealth University, Richmond

23602

Bon Secours Liver Institute of Virginia - Newport News, Newport News

27599

UNC Health Care System, Chapel Hill

27612

Wake Research Associates, Raleigh

28078

Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health, Huntersville

28204

Carolinas Medical Center, Charlotte

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28304

Cumberland Research Associates, LLC, Fayetteville

28403

Trial Management Associates, Wilmington

28557

Diabetes & Endocrinology Consultants, Morehead City

28677

Piedmont Healthcare, Statesville

28801

Asheville Gastroenterology Associates, Asheville

29010

Hospital Universitario Virgen de la Victoria, Málaga

29401

Ralph H. Johnson VA Medical Center, Charleston

29425

Medical University of South Carolina (MUSC), Charleston

Medical University of South Carolina, Charleston

30100

Research Site S.R.O., Pilsen

Research Site, s.r.o, Pilsen

30308

Emory University Hospital Midtown, Atlanta

30309

Piedmont Atlanta Hospital, Atlanta

30312

Atlanta Medical Center, Inc., Atlanta

30607

Summit Clinical Research, Athens

30625

Medizinische Hochschule Hannover (MHH), Hanover

31059

CHU Toulouse - Hôpital Purpan, Toulouse

32224

Mayo Clinic Hospital, Jacksonville

32610

University of Florida, Gainesville

33136

University of Miami - Miller School of Medicine, Miami

University of Miami - Schiff Center for Liver Diseases, Miami

33166

Integrity Clinical Research LLC, Doral

33414

South Florida Center of Gastroenterology, PA, Wellington

33434

Excel Medical Clinical Trials LLC, Boca Raton

33542

Florida Medical Clinic, PA, Zephyrhills

33604

Hôpital Haut-Lévêque, Pessac

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Çapa

Bezmiâlem Vakıf Üniversitesi, Fatih

34211

Atlantic Gastroenterology Associates, LLC, Lakewood Rch

34295

CHRU Montpellier- Hôpital Saint Eloi, Montpellier

34452

Nature Coast Clinical Research, Inverness

34766

Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi, Istanbul

34890

Marmara Üniversitesi Eğitim ve Araştırma Hastanesi, Pendik

35040

Ege Üniversitesi, Izmir

35294

University of Alabama at Birmingham, Birmingham

36071

Complexo Hospitalario Universitario de Pontevedra, Pontevedra

36305

Digestive Health Specialists of the Southeast, Dothan

37076

Associates in Gastroenterology, PLC, Hermitage

37211

Quality Medical Research, PLLC, Nashville

38103

Methodist University Hospital, Memphis

39008

Hospital Universitario Marqués de Valdecilla, Santander

39120

Universitätsklinikum Magdeburg, Magdeburg

39216

University of Mississippi Medical Center, Jackson

39232

Gastrointestinal Associates & Endoscopy Center, Flowood

39670

Centro de Investigación Clínica del Pacífico, S.A de C.V., Acapulco

40138

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

40202

University of Louisville Medical / Dental Complex, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

41014

Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS), Seville

41701

Gastroenterology Associates of Hazard, Hazard

43210

The Ohio State University Wexner Medical Center, Columbus

44093

CHU de Nantes - Hôpital Laennec, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

45147

Universitätsklinikum Essen, Essen

45249

Consultants for Clinical Research, Cincinnati

Ohio Gastroenterology & Liver Institute, Cincinnati

45267

Beth Israel Medical Center, New York

University of Cincinnati Physicians Company , LLC, Cincinnati

48202

Henry Ford Health System, Division of Gastroenterology & Hepatology, Detroit

49933

CHU Angers, Angers

50010

Hospital Universitario San Vicente de Paul Fundación, Medellín

50034

Hospital Pablo Tobon Uribe, Medellín

50937

Universitätsklinikum Köln, Cologne

Universitätsklinikum Köln, Cologne

52074

Universitätsklinikum RWTH Aachen, Aachen

53127

Universitätsklinikum Bonn, Bonn

54511

CHU Nancy - Hôpital Brabois, Vandœuvre-lès-Nancy

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60153

Loyola University Chicago, Maywood

60590

Universitätsklinikum Frankfurt - Goethe Universität, Frankfurt

60611

Northwestern Memorial Hospital - Arkes Family Pavilion, Chicago

60637

Rush University Medical Center, Chicago

The University of Chicago Medical Center, Chicago

University of Chicago, Chicago

63104

Saint Louis University School of Medicine, St Louis

64111

St. Luke's Liver Transplant & Specialist, Kansas City

64128

Kansas City VA Medical Center, Kansas City

64131

Kansas City Research Institute, Kansas City

65200

Yale University School of Medicine, Section of Digestive Diseases, New Haven

69004

Hôpital de la Croix-Rousse, Lyon

69120

Universitätsklinikum Heidelberg, Heidelberg

70112

Tulane University School of Medicine, New Orleans

71013

Ospedale Casa Sollievo della Sofferenza I.R.C.C.S., San Giovanni Rotondo

71105

Louisiana Research Center, LLC, Shreveport

72205

Liver Wellness Center, Little Rock

75012

Hôpital Saint-Antoine, Paris

75013

Hopital Pitie-Salpetriere, Paris

75014

Hôpital Cochin, Paris

75044

DHAT Research Institute, Garland

75203

Methodist Dallas Medical Center, Dallas

75234

Liver Center of Texas, Dallas

76012

Texas Clinical Research Institute, Arlington

76104

Baylor All Saints Medical Center - Baylor Research Institute, Fort Worth

77030

Baylor College of Medicine, Houston

Liver Associates of Texas, P.A., Houston

Research Specialists of Texas, Houston

77058

Centex Studies Inc., Houston

77098

Gulf Coast Research Group LLC, Houston

77904

Victoria Gastroenterology, Victoria

78215

The Texas Liver Institute, Inc., San Antonio

78229

Pinnacle Clinical Research, PLLC, San Antonio

78233

Gastroenterology Consultants of San Antonio, Live Oak

78234

Brooke Army Medical Center, Houston

78504

Centex Studies Inc, McAllen

78746

Pinnacle Clinical Research, PLLC, Rollingwood

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80054

CHU Amiens Picardie, Amiens

80113

South Denver Gastroenterology, Englewood

80131

"Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli", Napoli

84132

University of Utah School of Medicine, Salt Lake City

85006

Banner University Medical Center Phoenix, Phoenix

85013

Dignity Health St. Joseph's Hospital, Phoenix

85054

Mayo Clinic Hospital, Phoenix

85224

The Institute for Liver Health, Chandler

85306

The Institute for Liver Health, Glendale

85711

Institute for Liver Health, Tucson

85712

Adobe Clinical Research, LLC, Tucson

87042

CHU Limoges - Hôpital Dupuytren, Limoges

87109

Southwest Gastroenterology Associates, Albuquerque

89030

Rutgers, Robert Wood Johnson Medical School, New Brunswick

90033

Keck Hospital of USC, Los Angeles

90036

Ruane Clinical Research Group Inc., Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90067

Gastrointestinal Biosciences Clinical Trials LLC, Los Angeles

90073

Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center, Los Angeles

Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

90141

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

90822

VA Long Beach Healthcare System, Long Beach

91402

National Research Institute, Panorama City

91910

GW Research, Inc., Chula Vista

92037

Scripps Clinic Torrey Pines, La Jolla

University of California - San Diego, La Jolla

92056

Alliance Clinical Research, Oceanside

92064

Alliance Clinical Research, Poway

92103

University of California, San Diego Airway Research and Clinical Trials Center, San Diego

92110

Hôpital Beaujon, Clichy

92118

Southern California Research Center, Coronado

92123

Medical Associates Research Group, Inc., San Diego

92140

Hôpital Antoine-Béclère, Clamart

92161

VA San Diego HealthCare System, San Diego

92354

Loma Linda University Medical Center - Transplantation Insitute, Loma Linda

93003

Ventura Clinical Trials, Ventura

93720

Fresno Clinical Research Center, Fresno

93721

University of California, San Francisco, Fresno Community Regional Medical Center, Fresno

94000

Hôpital Henri Mondor, Créteil

94115

Quest Clinical Research, San Francisco

Sutter West Bay Hospitals dba California Pacific Medical Center, San Francisco

94143

University of California, San Francisco, Medical Center at Parnassus, San Francisco

94800

Hôpital Paul Brousse, Villejuif

95817

University of California, Davis Medical Center, Sacramento

96813

The Queen's Medical Center, Honolulu

97080

Universitätsklinikum Würzburg, Würzburg

98104

Swedish Organ Transplant and Liver Center, Seattle

109240

"FSBRI Federal Research Center of nutrition and biotechnology", Moscow

110221

Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO, Bogotá

119991

I. M. Sechenov - First Moscow State Medical University, Moscow

128041

Hospital Universitario 12 de Octubre, Madrid

129110

M. F. Vladimirsky - Clinical Research Institution of Moscow Region, Moscow

194044

Military medical academy n. a. S.M. Kirov, Saint Petersburg

197110

City Clinical Hospital No. 31, Saint Petersburg

St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31, Saint Petersburg

300002

SC Cabinet Particular Policlinic Algomed SRL, Timișoara

300736

"Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara", Timișoara

760032

Fundación Valle del Lili, Santiago de Cali

760042

Centro Medico Imbanaco, Santiago de Cali

1710209

Hospital de La Serena, La Serena

2540488

Clínica Reñaca, Viña del Mar

4430035

Alta Salud, Los Ángeles

8330024

Hospital Clínico UC, Santiago

8380456

Hospital Clínico Universidad de Chile, Santiago

8910108

Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment), Santiago

85724-0001

The University of Arizona College of Medicine Liver Research Institute, Tucson

93701-2302

University of California, San Francisco, Fresno Community Regional Medical Center, Fresno

34211-4930

Florida Digestive Health Specialists, LLP, Lakewood Rch

33125-1624

Miami VA Healthcare System, Miami

30060-8949

Gastrointestinal Specialists of Georgia, PC, Marietta

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center (BIDMC), Boston

06155

University of Massachusetts Memorial Medical Center, Worcester

07103

Rutgers, New Jersey Medical School, Newark

74104-4017

Options Health Research, LLC, Tulsa

02903

Rhode Island Hospital, Providence

76092-9167

Texas Digestive Consultants (TDDC), Southlake

98104-2420

Harborview Medical Center, Seattle

1180AAX

Sanatorio Güemes, Caba

C1430CKE

Axismed S.R.L, CABA

A4400ERH

Instituto Medico Alas, Salta

V5Z 1H2

LAIR Centre, Vancouver

V5Z 1M9

Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre, Vancouver

M5G 2C4

Toronto General Hospital, Toronto

Toronto Western Hospital, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

J4V 2H1

Monteregie Centre de Recherche, Greenfield Park

H4A 3J1

The Montreal Chest Institute, Montreal

Mc Gill University Health Centre (MUHC), Montreal

T2N 4Z6

University of Calgary, Cumming School of Medicine, Calgary, AB

B3H 1V7

Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax

R3E 3P4

University of Manitoba, Winnipeg, MB

04073-5820

Fundación Cardio Infantil - Instituto de Cardiología, Bogotá

050010

Fundacion Hospitalaria San Vicente de Paul, Medellín

625 00

Fakultní Nemocnice Brno, Brno

120 00

KlinMed s.r.o., Prague

00029

Helsinki University Central Hospital, Helsinki

06202

CHU de Nice- Hôpital de l'Archet II, Nice

Unknown

Gastroenterologie am Bayerischen Platz/ Gastro-Studien, Berlin

Hospital Maria Auxiliadora, Guadalajara

Consultorio Medico, Mexico City

Accelerium S de RL de C.V., Monterrey

04103

EUGASTRO GmbH, Leipzig

Universitätsklinikum Leipzig, Leipzig

00133

Policlinico Tor Vergata, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli, Roma

1081 HZ

Vrije Universiteit Medical Center, Amsterdam

1105 AZ

Academisch Medisch Centrum, Amsterdam

6229 HX

Maastricht UMC+, Maastricht

6525 GA

Radboud UMC, Nijmegen

3000-075

Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra

1169-050

Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria, Lisbon

4200-319

Centro Hospitalar de São João, EPE - Hospital de São João, Porto

Centro Hospitalar de São João, Porto

5000-508

Centro Hospita de Tras-os-Montes e Alto Douro, EPE, Vila Real

00745

Caparra Internal Medicine Research Center, Río Grande

00909

Klinical Investigations Group, LLC, San Juan

00927

Fundacion de Investigacion de Diego, San Juan

021105

"Institutul National de Boli Infectioase Prof. Dr. Matei Bals", Bucharest

022328

Institutul Clinic Fundeni, Bucharest

B15 2TT

University Hospitals Birmingham NHS foundation Trust, Birmingham

CB2 0QQ

Addenbrooke's Hospital, Cambridge

GU16 7UJ

Frimley Park Hospital NHS Foundation Trust, Frimley

HU3 2JZ

Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary, Hull

E1 1BB

Bart Health NHS Trust- Royal London Hospital, London

NW3 2QG

The Royal Free London NHS Foundation Trust - The Royal Free Hospital, London

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital, London

SW170QT

St George's University Hospitals NHS Foundation Trust - St George's Hospital, London

NE7 7DN

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

NG7 2UH

Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre, Nottingham

PL6 8DH

Plymouth Hospitals NHS Trust - Derriford Hospital, Plymouth

PO6 3LY

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genfit

INDUSTRY

NCT02704403 - Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) | Biotech Hunter | Biotech Hunter