Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

PHASE3CompletedINTERVENTIONAL
Enrollment

919

Participants

Timeline

Start Date

August 30, 2017

Primary Completion Date

September 8, 2022

Study Completion Date

September 8, 2022

Conditions
Compensated CirrhosisNonalcoholic Steatohepatitis
Interventions
DRUG

Obeticholic acid (10 mg)

Tablets administered orally once daily.

DRUG

Obeticholic acid (10 mg to 25 mg)

Tablets administered orally once daily.

DRUG

Placebo

Tablets administered orally once daily.

Trial Locations (192)

1036

Synexus Magyarország Kft. Budapest, Budapest

2025

Middlemore Hospital, Auckland

2747

Nepean Blue Mountains Local Health District, Nepean Hospital, Kingswood

3050

Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital, Fitzroy

3084

Austin Health, Heidelberg

4025

Synexus Magyarorszag Kft. Debrecen A.S., Debrecen

4101

Mater Misericordiae Limited, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

5700

Synexus Magyarorszag Kft. Gyula DRS, Gyula

6021

Dunedin Public Hospital, Dunedin

Wellington Regional Hospital, Wellington

8011

Christchurch Hospital, Christchurch

10003

Ichan School of Medicine at Mount Sinai Beth Israel, New York

10016

NYU Langone Health, New York

10021

Weill Cornell Medical College, New York

10467

Montefiore Medical Center, The Bronx

13353

Charité - Universitätsmedzin Berlin, Berlin

14203

University at Buffalo, Clinical and Translational Research Center, Buffalo

14642

University of Rochester Medical Center, Rochester

15213

UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute, Pittsburgh

17033

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

18017

Northeast Clinical Research Center, LLC, Bethlehem

19107

Thomas Jefferson University, Philadelphia

19141

Einstein Healthcare Network, Philadelphia

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

23226

Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours, Richmond

23249

McGuire VA Medical Center, Richmond

23298

Virginia Commonwealth University, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads, Newport News

24014

Gastroenterology Consultants of Southwest Virginia, Roanoke

24146

Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel

27599

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

27710

Duke University Medical Center, Durham

28046

Hospital Universitario La Paz, Madrid

28078

Carolinas Center for Liver Disease/Carolinas HealthCare System, Huntersville

Carolinas Health Care System Center for Liver Disease, Huntersville

28207

Charlotte Gastroenterology & Hepatology, PLLC, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

28403

Trial Management Associates, LLC, Wilmington

28557

Diabetes & Endocrinology Consultants, PC, Morehead City

28801

Asheville Gastroenterology Associates, P.A., Asheville

29401

Ralph H. Johnson Veterans Affairs Medical Center, Charleston

29425

SCTR Research Nexus, Charleston

30060

Gastrointestinal Specialists of Georgia, Marietta

30322

The Emory Clinic (TEC), Atlanta

30607

Summit Clinical Research, LLC, Athens

31059

Hôpital Purpan, Toulouse

32207

UF Health Jacksonville-Gastroenterology Emerson, Jacksonville

32224

Mayo Clinic Florida, Jacksonville

32503

Gastroenterology Associates of Pensacola, PA, Pensacola

33134

Hi Tech and Global Research LLC, Coral Gables

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33157

Innovation Medical Research Center, Palmetto Bay

33180

Innovative Medical Research of South Florida, Inc., Aventura

33542

Florida Medical Clinic, P.A, Zephyrhills

33606

Tampa General Medical Group, Tampa

33614

Guardian Angel Research Center, INC, Tampa

34452

Nature Coast Clinical Research, Inverness

34761

Sensible Healthcare, LLC, Ocoee

35758

Objective GI d/b/a North Alabama GI Research Center, Madison

36305

Digestive Health Specialists of the Southeast, Dothan

37076

Associates in Gastroenterology, PLC, Hermitage

37211

Quaility Medical Research, PLLC, Nashville

37232

Vanderbilt University Medical Center - Digestive Disease Center, Nashville

37604

Johnson City Medical Center, Johnson City

38104

Methodist Healthcare University Hospital, Memphis

38138

Gastro One, Germantown

38700

Center Hospitalier Universitaire Grenoble Alpes, La Tronche

39008

Hospital Universitario Marqués de Valdecilla, Santander

39216

Southern Therapy and Advanced Research (STAR) LLC, Jackson

University of Mississippi Medical Center, Jackson

40202

University of Louisville, Clinical Trials Unit, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

43210

The Ohio State University Wexner Medical Center, Columbus

45440

Dayton Gastroenterology, Inc., Beavercreek

46014

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari i Politécnic La Fe, Valencia

47150

Aquiant Research, New Albany

48197

Huron Gastroenterology Associates, Ypsilanti

49519

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

49933

Centre Hospitalier Universitaire d'Angers, Angers

54511

CHRU de Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy

55114

Minnesota Gastroenterology, P.A., Saint Paul

55131

Universitätsmedizin Mainz, Mainz

57701

Rapid City Medical Center LLP, Rapid City

60153

Loyola University Medical Center, Maywood

60594

Teuber Consulting & Research UG, Frankfurt am Main

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

64131

Kansas City Research Institute, Kansas City

66160

University of Kansas Medical Center, Kansas City

66606

Kansas Medical Clinic, Topeka

67000

Centre Hospitalier Universitaire de Strasbourg, Strasbourg

67200

Hôpital Hautepierre, Strasbourg

68124

CHI Health Alegent Creighton Clinic, Omaha

69317

Hôpital de la Croix Rousse, Lyon

70072

Tandem Clinical Research, LLC, Marrero

70112

Tulane University Health Sciences Center, New Orleans

71105

Louisiana Research Center, Shreveport

71201

Delta Research Partners, LLC, Monroe

72117

Arkansas Gastroenterology, North Little Rock

72205

Liver Wellness Center, Little Rock

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

75651

Hôpital Pitié-Salpêtrierè, Paris

76012

Texas Clinical Research Institute LLC, Arlington

76031

CHU de Rouen-Centre Hospitalier Universitaire, Rouen

76104

Baylor Scott and White All Saints Medical Center, Fort Worth

Texas Digestive Disease Consultants, Fort Worth

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

The University of Texas Medical School at Houston, Houston

78215

American Research Corporation, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

78234

San Antonio Military Medical Center, Fort Sam Houston

78504

Centex Studies, Inc., McAllen

78666

Texas Digestive Disease Consultants, San Marcos

80045

University of Colorado Denver and Hospital, Aurora

80054

CHU Amiens Picardie, Amiens

80113

South Denver Gastroenterology, PC, Englewood

80907

Peak Gastroenterology Associates, Colorado Springs

83404

Grand Teton Research Group, PLLC, Idaho Falls

85224

Arizona Liver Health, Chandler

85306

Arizona Liver Health, Glendale

85712

The Institute for Liver Health, Tucson

89106

Sierra Clinical Research, Las Vegas

90033

Keck Hospital of USC, Los Angeles

90048

Cedars-Sinani Medical Center, Los Angeles

91105

California Liver Research Institute, Pasadena

91303

Hope Clinical Research, Canoga Park

91942

eStudySite, La Mesa

92037

Scripps Whittier Diabetes Institute, La Jolla

92110

Hôpital Beaujon- Service d'Hepatologie, Clichy

92262

Palmtree Clinical Research, INC., Palm Springs

92377

Inland Empire Liver Foundation, Rialto

93701

University of California, San Francisco-Fresno, Fresno

94143

University of California, San Francisco, San Francisco

94304

Stanford University Medical Center, Palo Alto

94800

Hôpital Paul Brousse, Villejuif

95817

University of California, Davis Medical Center, Sacramento

95825

Kaiser Permanente Sacramento Medical Center, Sacramento

97080

Univeritätsklinkum Würzburg, Würzburg

98101

Virginia Mason - Seattle Medical Center, Seattle

98104

Harborview Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

01805

Lahey Hospital & Medical Center, Burlington

01655

UMass Memorial Health Care, Worcester

08836

Amici GI-LLC, Martinsville

07103

Rutgers New Jersey Medical School, Newark

02905

University Gastroenterology, Providence

05401

The University of Vermont Medical Center, Burlington

T2M 4Z6

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

V6Z 2K5

(G.I.R.I.) GI Research Institute, Vancouver

B3H 2Y9

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

K9V 5G6

Kent Place, Lindsay

N6A 5A5

London Health Sciences Centre-University Hospital, London

PIB 2H3

Office of Dr. Gauthier, North Bay

V5Z 1H2

Toronto Liver Centre, Toronto

H2L 4E9

Clinique de medecine Urbaine du Quartier Latin, Montreal

H4A 3JI

Chronic Viral Illness/McGill University Health Centre (MUHC), Montreal

06202

CHU de Nice, Hôpital de l'Archet 2, Nice

04103

EUGASTRO GmbH, Leipzig

Universitätsklinikum Leipzig AöR, Leipzig

42-200

Synexus Polska Sp. z o.o., Oddział w Częstochowie, Częstochowa

80-382

Synexus Polska Sp. z.o.o., Oddział w Gdańsku, Gdansk

81-537

Synexus Polska Sp. Z.o.o., Oddział w Gdyni, Gdynia

40-040

Synexus Polska Sp. z o.o., Oddział w Katowicach, Katowice

90-127

Synexus Polska Sp. z o.o., Oddział w Łodzi, Lodz

60-702

Synexus Polska Sp. z o.o., Oddział w Poznaniu, Poznan

01-192

Synexus Polska Sp. z o.o., Oddział w Warszawie, Warsaw

50-381

Synexus Polska Sp. z o.o., Oddział w Wrocławiu, Wroclaw

00909

Latin Clinical Trial Center, San Juan

00927

Fundación de Investigación de Diego, San Juan

08036

Hospital Clínic de Barcelona, Barcelona

03037

Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department, Kyiv

03049

"Kyiv Railway Clinical Hospital №2 of branch Health Center of the Joint-Stock Company Ukranian Railway, Day treatment department", Kyiv

DE22 3NE

Derby Teaching Hospitals NHS Foundation Trust, Derby

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

NW3 2QG

Royal Free Hospital NHS Foundation Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

W2 INY

Imperial College Healthcare NHS Trust, St Mary's Hospital, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

NE7 7DN

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

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY