Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,477

Participants

Timeline

Start Date

September 22, 2015

Primary Completion Date

September 15, 2023

Study Completion Date

September 15, 2023

Conditions
Non Alcoholic Steatohepatitis (NASH)
Interventions
DRUG

Obeticholic Acid

DRUG

Placebo

Trial Locations (346)

1023

NZ Liver Transplant Unit, Grafton

1070

ULB Hȏpital Erasme - Gastroenterology, Brussels

1090

Medizinische Universität Wien, Vienna

1097

Egyesitett Szent Istvan és Szent Laszlo, Budapest

1200

UCL Saint-Luc - Hepatology Department, Brussels

2025

Middlemore Hospital, Auckland

2050

AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2650

UZ Antwerpen, Edegem

Copenhagen University Hospital Hvidovre, Hvidovre

2747

Nepean Hospital, Kingswood

3000

UZ Leuven Campus Gathuisberg Hepatology Department, Leuven

3004

The Alfred Hospital, Department of Gastroenterology, Melbourne

3010

UVCM Hepatologie, Bern

3053

The Royal Melbourne Hospital, Parkville

3084

Austin Hospital, Heidelberg

3168

Monash Health - Monash Medical Centre, Clayton

3600

Ziekenhuis Oost-Limburg (ZOL), Genk

4010

Ordensklinikum Linz GmbH, Linz

4029

Royal Brisbane and Women's Hospital, Herston

4031

Kenezy Gyula Korhaz es Rendelointezet, Debrecen

4120

Gallipoli Medical Research Foundation, Greenslopes

5000

Royal Adelaide Hospital Gastroenterology and Hepatology Dept., Adelaide

Odense University Hospital, Odense

5020

Uniklinikum Salzburg, Salzburg

5042

Flinders Medical Centre, Bedford Park

6020

Universitätsklinik für Innere Medizin I Innsbruck, Innsbruck

6150

Fiona Stanley Hospital, Murdoch

6202

Hôpital de l'Archet II-CHU Nice, Nice

6900

Epatocentro Ticino, Lugano

7624

Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz, Budapest

8091

University Clinic of Gastroenterology & Hepatology, Zurich

8200

Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling, Aarhus

9000

UZ Gent Gastroenterology Department, Ghent

9001

Aalborg University Hospital, Aalborg

9007

Hospital of St. Gallen, Sankt Gallen

9020

Klinikum Klagenfurt am Wörthersee, Klagenfurt

9100

AZ Nikolaas, Sint-Niklaas

10003

Mount Sinai Beth Israel, New York

10016

Concorde Medical Group PLLC, New York

New York University (NYU) Langone Medical Center, New York

10021

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mt. Sinai, New York

10032

Columbia University Medical Center, New York

10126

A.O.U. Città della Salute e della Scienza di Torino, Torino

10467

Montefiore Medical Center, The Bronx

11000

University Medical Centar Zvezdara, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

13008

Hôpital Saint Joseph, Marseille

13353

Charite Universitätsmedizin Campus Virchow, Berlin

14203

University at Buffalo, Clinical and Translational Research Center, Buffalo

14642

University of Rochester Medical Center, Rochester

15213

UPMC, Pittsburgh

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16100

Holy Family Medical Center, Nazareth

17033

The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey

18000

Clinical Center Nis, Niš

18901

Doylestown Health Gastroenterology, Doylestown

19031

Hillmont GI, pc, Flourtown

19102

Drexel University, Philadelphia

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19141

Einstein Healthcare Network, Philadelphia

19446

Hillmont G.I. - Lansdale Office, Lansdale

20014

Hospital Universitario Donostia, Donostia / San Sebastian

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale, Milan

20123

Ospedale san Giuseppe - Multimedica, Milan

20142

Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo, Milan

20246

Universitätsklinikum Hamburg- Eppendorf, Hamburg

20520

Turku University Hospital, Turku

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

21287

Johns Hopkins Hospital, Baltimore

21401

Investigative Clinical Research, Annapolis

22042

Inova Fairfax Medical Campus, Falls Church

22100

West Galilee Hospital, Nahariya

22908

University of Virginia Health System, Charlottesville

23226

Bon Secours St. Mary's Hospital, Richmond

23249

McGuire DVAMC GI, Richmond

23298

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

23502

Digestive and Liver Disease Specialists, Norfolk

24071

Complejo Asistencial Universitario de Leon, León

24146

Hepato-Gastroenterology Center Kiel, Kiel

27103

Digestive Health Specialists, PA, Winston-Salem

27710

Duke University Medical Center, Durham

28034

Hospital Universitario Ramón y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28078

Carolinas Center for Liver Disease/Carolinas HeatlhCare System, Huntersville

28204

Center for Liver Disease, Charlotte

28207

Charlotte Gastroenterology & Hepatology, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

28304

Cumberland Research Associates, LLC, Fayetteville

28801

Asheville Gastroenterology Associates, PA, Asheville

28922

Hospital Universitario Fundación Alcorcon, Alcorcón

29010

Hospital (Universitario) Virgen de la Victoria, Málaga

29605

Prisma Health- Upstate Gastroenterology and Liver Center, Greenville

30060

Gastrointestinal Specialists of Georgia, Marietta

30309

Digestive Healthcare of Georgia, Atlanta

Piedmont Atlanta Hospital, Atlanta

30322

The Emory Clinic (TEC), Atlanta

30607

Summit Clinical Research, LLC, Athens

30625

Medizinische Hochschule Hannover, Hanover

31059

CHU Toulouse - Hopital de Purpan, Toulouse

32207

UF Health Jacksonville-Gastroenterology Emerson, Jacksonville

32224

Mayo Clinic, Jacksonville

32610

UF Hepatology Research at CTRB, Gainesville

32751

Meridien Research, Maitland

32804

Florida Hospital Transplant Institute, Orlando

33125

Bruce W. Carter Miami VA Medical Center, Miami

33136

Schiff Center for Liver Diseases, Miami

33166

Integrity Clinical Research, LLC, Doral

33175

ProLive Medical Research, Miami

33186

Janus Clinical Research, Inc., Miami

33319

Sunrise Medical Research, Inc., Lauderdale Lakes

33414

South Florida Center of Gastroenterology, P.A., Wellington

33542

Florida Medical Clinic, P.A., Zephyrhills

33604

Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN, Pessac

34211

Florida Digestive Health Specialist Research Institute, Lakewood Rch

34362

Carmel Medical Center, Haifa

34452

Nature Coast Clinical Research, Inverness

34761

Sensible Healthcare, LLC, Ocoee

35294

The University of Alabama at Birmingham, Birmingham

36305

Digestive Health Specialists of the Southeast, Dothan

37076

Associates in Gastroenterology, PLC, Hermitage

37205

Nashville Gastrointestinal Specialists, Nashville

37211

Quality Medical Research, PLLC, Nashville

37232

Vanderbilt University Medical Center, Nashville

37421

WR-Clinsearch, LLC, Chattanooga

37604

East Tennesse Research Institute, Johnson City

38104

Methodist Healthcare, University Hospital, Memphis

38138

Gastro One, Germantown

38300

Centre hospitalier Pierre Oudot, Bourgoin

38305

Clinical Research Solutions, Jackson

38700

CHU Grenoble, Grenoble

39008

Hospital (Universitario) Marqués de Valdecilla, Santander

39216

Southern Therapy and Advanced Research, LLC, Jackson

40138

Universita di Bologna - DIMEC, Bologna

University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC, Bologna

40202

University of Louisville Medical, Clinical Trials Unit, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

41013

Hospital Universitario Virgen del Rocio, Seville

41126

AOU di Modena Ospedale Civile, Modena

42101

The Medical Center of Bowling Green, Bowling Green

43203

The Ohio State University Wexner Medical Center, Columbus

44106

University Hospitals Case Medical Center, Cleveland

44109

MetroHealth Medical Center, Cleveland

44623

Gastroenterologische Gemeinschaftspraxis, Herne

44791

St. Josef-Hospital, Ruhr University Bochum, Bochum

45100

Service d'Hepato-Gastroenterologie CHR Orleans - La Source, Orléans

45147

University Hospital Essen, Essen

45249

Consultants for Clinical Research, Cincinnati

45257

Katholische Kliniken Ruhrhalbinsel GmbH, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

46014

Consorcio Hospital General Universitario, Valencia

46026

Hospital Universitario La Fe., Valencia

46202

Indiana University Health University Hospital, Indianapolis

46237

Indianapolis Gastroenterology & Hepatology, Indianapolis

48197

Huron Gastroenterology Associates/Center for Digestive Care, Ypsilanti

48202

Henry Ford Health System, Detroit

49519

Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research, Wyoming

49933

CHU Angers-Service d'Hepato-Gastroenterologie, Angers

50009

Hospital Universitario Miguel Servet, Zaragoza

50937

University Hosptial Cologne Clinics for Gastroenterology and Hepatology, Cologne

52074

Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III, Aachen

52621

Sheba Medical Center, Ramat Gan

53705

University of Wisconsin Hospital & Clinics, Madison

54500

CHU de Nancy - Hôpital de Brabois adultes, Vandœuvre-lès-Nancy

55131

Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik, Mainz

55413

Minnesota Gastroenterology, Minneapolis

55905

Mayo Clinic, Rochester

57701

Rapid City Medical Center, Rapid City

59037

CHRU Hôpital Claude Huriez, Lille

60153

Loyola University Medical Center, Maywood

60611

Northwestern University, Feinberg School of Medicine, Chicago

60637

The University of Chicago Medical Center, Chicago

63104

Saint Louis University Gastroenterology & Hepatology, St Louis

63110

Washington University School of Medicine - Gastroenterology, St Louis

64128

Kansas City VA Medical Center, Kansas City

64131

Kansas City Research Institute, Kansas City

64239

Sourasky Tel-Aviv Medical Center, Tel Aviv

66160

The University of Kansas Medical Center, Kansas City

68124

CHI Health Alegent Creighton Clinic Gastroenterology, Omaha

69004

Hôpital de la Croix Rousse, Lyon

69120

Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie, Heidelberg

70112

Tulane Medical Center, New Orleans

70121

Ochsner Clinic Foundation, New Orleans

71105

Louisiana Research Center, LLC, Shreveport

72117

Arkansas Gastroenterology, North Little Rock

72205

Liver Wellness Center, Little Rock

73112

INTEGRIS Baptist Medical Center, Oklahoma City

75012

Hospital Saint Antoine Department of Hepatology, Paris

75013

Hôpital de la Pitié Salpétrère, Paris

75014

Hôpital Cochin, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75234

Liver Center of Texas, Dallas

75246

Texas Digestive Disease Consultants, Dallas

75390

UT Southwestern Medical Center, Dallas

76012

Texas Clinical Research Institute, Arlington

76031

CHU de Rouen, Rouen

76104

Baylor Scott & White All Saints Medical Center, Fort Worth

Texas Digestive Disease Consultants, Fort Worth

77030

Baylor College of Medicine Ben Taub General Hospital, Houston

Baylor College of Medicine, Houston

Houston Methodist Hospital, Houston

Liver Associates of Texas, P.A., Houston

The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition, Houston

77058

Centex Studies, Inc., Houston

78215

American Research Corporation at the Texas Liver Institute, San Antonio

78229

Gastroenterology Consultants of San Antonio, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

78504

Centex Studies, Inc., McAllen

78666

Texas Digestive Disease Consultants - San Marcos, San Marcos

79935

MedResearch, Inc., El Paso

80033

Western States Clinical Research, Inc., Wheat Ridge

80045

University of Colorado Denver and Hospital, Aurora

80054

CHU Amiens Picardie, Amiens

80113

South Denver Gastroenterology, PC, Englewood

80131

Azienda Ospedaliera Universitaria Policlinico, Napoli

80639

Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie, Munich

83404

Grand Teton Research Group, Idaho Falls

84101

Soroka Medical Center Division of Internal Medicine, Beersheba

84132

University of Utah Hospital, Salt Lake City

85013

St. Joseph's Hospital and Medical Center, Phoenix

85054

Mayo Clinic Arizona, Phoenix

85224

Institute for Liver Health DBA Arizona Liver Health, Chandler

85306

Arizona Liver Health - Glendale, Glendale

85711

Arizona Liver Clinic - Tucson, Tucson

87109

AccumetRx Clinical research / UGNM, Albuquerque

90033

Keck Medical Center of USC, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90057

National Research Institute, Wilshire, Los Angeles

90067

Gastrointestinal Biosciences, Los Angeles

90073

Veteran Affairs Great Los Angeles Healthcare System, Los Angeles

90127

Policlinico Paolo Giaccone di Palermo, Palermo

91054

Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1, Erlangen

91120

Hadassah Ein Kerem MC, Jerusalem

91722

Citrus Valley Gastroenterology, Covina

91910

GW Research Inc., Chula Vista

Precision Research Institute, Chula Vista

92020

TriWest Research Associates, LLC, El Cajon

92037

Scripps Clinic, La Jolla

University of California, San Diego, La Jolla

92110

CHU Beaujon-Service d'Hépatologie, Clichy

92118

Southern California Research Center, Coronado

92120

eStudy Site, San Diego

92123

Medical Associates Research Group, San Diego

92154

Kaiser Permanente, San Diego

92377

Inland Empire Liver Foundation, Rialto

93701

UCSF Fresno, Clinical Research Center, Fresno

93720

Fresno Clinical Research Center, Fresno

94000

Hôpital Henri Mondor - Service d'hépatologie, Créteil

94109

California Pacific Medical Center (CPMC), San Francisco

94110

UCSF/ San Francisco General Hospital, San Francisco

94115

Quest Clinical Research, San Francisco

94143

University of California, San Francisco, San Francisco

94304

Stanford University, Palo Alto

94804

Hopital Paul Brousse, Villejuif

95128

Silicon Valley Research Institute, San Jose

95817

University of California Davis Medical Center, Sacramento

96813

The Queen's Medical Center - Liver Center, Honolulu

97080

Universitätsklinikum Würzburg, Würzburg

98101

Virginia Mason - Seattle Medical Center, Seattle

98104

Swedish Organ Transplant and Liver Center, Seattle

98105

Liver Institute Northwest, Seattle

98195

University of Washington Medical Center, Seattle

3109601

Rambam Medical Center Center for Liver diseases, Haifa

4941492

Rabin Medical Center, Liver Institute, Petah Tikva

06520

Yale University School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01805

Lahey Hospital & Medical Center, Burlington

01655

University of Massachusetts Medical School, Worcester

08234

AGA Clinical Research Associates, LLC, Egg Harbor

08836

Amici Clinical Research, Martinsville

Amici GI - LLC, Martinsville

07103

Rutgers University New Jersey Medical School, Newark

07503

Saint Joseph's Regional Medical Center, Paterson

27599-7584

University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill

45267-0595

University of Cincinnati, Cincinnati

02905

University Gastroenterology, Providence

05401

The University of Vermont Medical Center - Smith 2, Burlington

B-8000

AZ Sint-Jan Brugge Oostende, Bruges

N6A 5A5

London Health Sciences Centre University Hospital, London

T2N 4Z6

University of Calgary Liver Unit, Calgary

T5H 4B9

GI Research, Edmonton

T6G 2X8

University of Alberta, Edmonton

H2X 0A9

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal, Montreal

H4A 3J1

The Research Institute of the McGill University Health Centre, Montreal

M5G 2C4

Toronto Center for Liver Disease, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

V5Z 1H3

LAIR Centre, Vancouver

V5Z 1M9

Gordon and Leslie Diamond Health Care Centre, Vancouver

V6Z 2K5

GIRI - GI Research Institute, Vancouver

V8V 3M9

PerCuro Clinical Research Ltd., Victoria

R3E 3P4

John Buhler Research Centre, Winnipeg

00290

Helsinki University Hospital, Helsinki

04103

Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie, Leipzig

EUGASTRO GmbH, Leipzig

03235

Shaarei Zedek Medical Center, Jerusalem

Unknown

Fondazione IRCCS Ca Grande Ospedale, Milan

00128

Policlinico University Campus Biomedico, Rome

80-546

Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk

40-752

Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

91-347

Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

51-349

Centrum Badan Klinicznych Piotr Napora, Wroclaw

3814-201

Centro Hospitalar do Baixo Vouga, E.P.E., Aveiro

7801-849

Ulsba, Epe, Beja

4835-044

Hospital da Senhora da Oliveira - Guimarães, Guimarães

1349-019

Centro Hospitalar Lisboa Ocidental, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria, Lisbon

00909

Klinical Investigations Group, LLC, San Juan

00918

Ave Ponce De Leon #715, San Juan

00927

Fundacion de Investigacion, San Juan

07120

Hospital Universitari Son Espases, Palma de Mallorca

03010

Hospital General y Universitario de Alicante, Alicante

08003

Hospital del Mar Gastroenterology Department, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic(o) de Barcelona, Barcelona

SE-413 45

Sahlgrenska University Hospital, Gothenburg

SE-581 85

Universitetsjukhuset Linkoping, Linköping

SE-141 86

Karolinska University Hospital, Stockholm

TR1 3LJ

Royal Cornwall Hospital, Truro

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

PO6 3LY

Queen Alexandra Hospital, Portsmouth

NR4 7UY

Norfolk and Norwich University Hospitals, Norwich

OX3 9DU

John Radcliffe Hospital, Headington

GU27XX

Royal Surrey NHS Foundation Trust, Guildford

B15 2TT

Institute of Biomedical Research, Birmingham

BD9 6RJ

Bradford Royal Infirmary, Bradford

BS2 8HW

University Hospital Bristol NHS Foundation Trust, Bristol

CB2 0QQ

Cambridge University Hospital, Cambridge

CV2 2DX

University Hospitals Coventry & Warwickshire, Coventry

G4 0SF

Glasgow Royal Infirmary, NHS Greater, Glasgow

HU3 2JZ

Gastroenterology Department Hull Royal Infirmary, Hull

L9 7AL

University Hospital Aintree, Liverpool

E1 1FR

Royal London Hospital, London

NW3 2QG

Institute for Liver and Digestive Health, London

SE1 9RT

Guy's and St. Thomas NHS Foundation Trust, London

W2 1NY

St. Mary's Hospital, London

M13 9WL

Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary, Manchester

NE7 7DN

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NG7 2UH

Nottingham Digestive Diseases and Biomedical Research Unit, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY

NCT02548351 - Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment | Biotech Hunter | Biotech Hunter