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

September 5, 2024 updated by: Intercept Pharmaceuticals

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2477

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital Gastroenterology and Hepatology Dept.
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Camperdown, Australia, 2050
        • AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital
      • Clayton, Australia, 3168
        • Monash Health - Monash Medical Centre
      • Greenslopes, Australia, 4120
        • Gallipoli Medical Research Foundation
      • Heidelberg, Australia, 3084
        • Austin Hospital
      • Herston, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Kingswood, Australia, 2747
        • Nepean Hospital
      • Melbourne, Australia, 3004
        • The Alfred Hospital, Department of Gastroenterology
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • Parkville, Australia, 3053
        • The Royal Melbourne Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik für Innere Medizin I Innsbruck
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
      • Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Brugge, Belgium, B-8000
        • AZ Sint-Jan Brugge Oostende
      • Brussels, Belgium, 1200
        • UCL Saint-Luc - Hepatology Department
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg (ZOL)
      • Ghent, Belgium, 9000
        • UZ Gent Gastroenterology Department
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Brabant
      • Brussels, Brabant, Belgium, 1070
        • ULB Hȏpital Erasme - Gastroenterology
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven Campus Gathuisberg Hepatology Department
  • Canada
      • Calgary, Canada, T2N 4Z6
        • University of Calgary Liver Unit
      • Edmonton, Canada, T5H 4B9
        • GI Research
      • Edmonton, Canada, T6G 2X8
        • University of Alberta
      • Montreal, Canada, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
      • Montreal, Canada, H4A 3J1
        • The Research Institute of the McGill University Health Centre
      • Toronto, Canada, M5G 2C4
        • Toronto Center for Liver Disease
      • Toronto, Canada, M6H 3M1
        • Toronto Liver Centre
      • Vancouver, Canada, V5Z 1H3
        • Lair Centre
      • Vancouver, Canada, V5Z 1M9
        • Gordon and Leslie Diamond Health Care Centre
      • Vancouver, Canada, V6Z 2K5
        • GIRI - GI Research Institute
      • Victoria, Canada, V8V 3M9
        • PerCuro Clinical Research Ltd.
      • Winnipeg, Canada, R3E 3P4
        • John Buhler Research Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre University Hospital
  • Denmark
      • Aalborg, Denmark, 9001
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital Hvidovre
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Hospital
      • Turku, Finland, 20520
        • Turku University Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie
      • Angers, France, 49933
        • CHU Angers-Service d'Hepato-Gastroenterologie
      • Bourgoin-Jallieu, France, 38300
        • Centre Hospitalier Pierre Oudot
      • Clichy, France, 92110
        • CHU Beaujon-Service d'Hépatologie
      • Creteil, France, 94000
        • Hôpital Henri Mondor - Service d'hépatologie
      • Grenoble, France, 38700
        • CHU Grenoble
      • Lille, France, 59037
        • CHRU Hopital Claude Huriez
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Nice, France, 6202
        • Hôpital de l'Archet II-CHU Nice
      • Orléans, France, 45100
        • Service d'Hepato-Gastroenterologie CHR Orleans - La Source
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75012
        • Hospital Saint Antoine Department of Hepatology
      • Paris, France, 75013
        • Hôpital de la Pitié Salpétrère
      • Pessac, France, 33604
        • Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN
      • Rouen, France, 76031
        • CHU de Rouen
      • Toulouse, France, 31059
        • CHU Toulouse - Hopital de Purpan
      • Vandoeuvre-Lès-Nancy, France, 54500
        • CHU de Nancy - Hôpital de Brabois Adultes
      • Villejuif, France, 94804
        • Hopital Paul Brousse
  • Germany
      • Aachen, Germany, 52074
        • Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III
      • Berlin, Germany, 13353
        • Charite Universitätsmedizin Campus Virchow
      • Bochum, Germany, 44791
        • St. Josef-Hospital, Ruhr University Bochum
      • Cologne, Germany, 50937
        • University Hosptial Cologne Clinics for Gastroenterology and Hepatology
      • Essen, Germany, 45147
        • University Hospital Essen
      • Essen, Germany, 45257
        • Katholische Kliniken Ruhrhalbinsel GmbH
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg- Eppendorf
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Herne, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis
      • Kiel, Germany, 24146
        • Hepato-Gastroenterology Center Kiel
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH
      • Munich, Germany, 80639
        • Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie
  • Hungary
      • Budapest, Hungary, 1097
        • Egyesitett Szent Istvan és Szent Laszlo
      • Budapest, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz
      • Debrecen, Hungary, 4031
        • Kenezy Gyula Korhaz es Rendelointezet
  • Israel
      • Be'er Sheva, Israel, 84101
        • Soroka Medical Center Division of Internal Medicine
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center Center for Liver diseases
      • Jerusalem, Israel, 03235
        • Shaarei Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Ein Kerem MC
      • Nahariya, Israel, 22100
        • West Galilee Hospital
      • Nazareth, Israel, 16100
        • Holy Family Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center, Liver Institute
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Sourasky Tel-Aviv Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Universita di Bologna - DIMEC
      • Bologna, Italy, 40138
        • University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC
      • Milan, Italy, 20123
        • Ospedale san Giuseppe - Multimedica
      • Milano, Italy, 20122
        • Fondazione IRCCS ca Granda Ospedale
      • Milano, Italy, 20142
        • Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo
      • Milano, Italy
        • Fondazione IRCCS Ca Grande Ospedale
      • Modena, Italy, 41126
        • AOU di Modena Ospedale Civile
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Policlinico
      • Palermo, Italy, 90127
        • Policlinico Paolo Giaccone di Palermo
      • Rome, Italy, 00128
        • Policlinico University Campus Biomedico
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e Della Scienza di Torino
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • NZ Liver Transplant Unit
  • Poland
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Katowice, Poland, 40-752
        • Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1
      • Wroclaw, Poland, 51-349
        • Centrum Badan Klinicznych Piotr Napora
  • Portugal
      • Aveiro, Portugal, 3814-201
        • Centro Hospitalar do Baixo Vouga, E.P.E.
      • Beja, Portugal, 7801-849
        • Ulsba, Epe
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira - Guimarães
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria
      • Lisbon, Portugal, 1349-019
        • Centro Hospitalar Lisboa Ocidental
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion
      • San Juan, Puerto Rico, 00909
        • Klinical Investigations Group, LLC
      • San Juan, Puerto Rico, 00918
        • Ave Ponce De Leon #715
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • University Medical Centar Zvezdara
      • Nis, Serbia, 18000
        • Clinical Center Nis
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Alicante, Spain, 03010
        • Hospital General y Universitario de Alicante
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08003
        • Hospital del Mar Gastroenterology Department
      • Barcelona, Spain, 08036
        • Hospital Clinic(o) de Barcelona
      • Leon, Spain, 24071
        • Complejo Asistencial Universitario de Leon
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Malaga, Spain, 29010
        • Hospital (Universitario) Virgen de la Victoria
      • San Sebastian, Spain, 20014
        • Hospital Universitario Donostia
      • Santander, Spain, 39008
        • Hospital (Universitario) Marqués de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe.
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07120
        • Hospital Universitari Son Espases
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
  • Sweden
      • Gothenburg, Sweden, SE-413 45
        • Sahlgrenska University Hospital
      • Linkoping, Sweden, SE-581 85
        • Universitetsjukhuset Linkoping
      • Stockholm, Sweden, SE-141 86
        • Karolinska University Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • UVCM Hepatologie
      • Lugano, Switzerland, 6900
        • Epatocentro Ticino
      • St.Gallen, Switzerland, 9007
        • Hospital of St. Gallen
      • Zürich, Switzerland, 8091
        • University Clinic of Gastroenterology & Hepatology
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Institute of Biomedical Research
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS2 8HW
        • University Hospital Bristol NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary, NHS Greater
      • Hull, United Kingdom, HU3 2JZ
        • Gastroenterology Department Hull Royal Infirmary
      • Liverpool, United Kingdom, L9 7AL
        • University Hospital Aintree
      • London, United Kingdom, E1 1FR
        • Royal London Hospital
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, NW3 2QG
        • Institute for Liver and Digestive Health
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas NHS Foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham Digestive Diseases and Biomedical Research Unit
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
    • Surrey
      • Guildford, Surrey, United Kingdom, GU27XX
        • Royal Surrey NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists Of The Southeast
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Institute for Liver Health DBA Arizona Liver Health
      • Glendale, Arizona, United States, 85306
        • Arizona Liver Health - Glendale
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Liver Clinic - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Liver Wellness Center
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Chula Vista, California, United States, 91910
        • Precision Research Institute
      • Chula Vista, California, United States, 91910
        • GW Research Inc.
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Covina, California, United States, 91722
        • Citrus Valley Gastroenterology
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Fresno, California, United States, 93720
        • Fresno Clinical Research Center
      • Fresno, California, United States, 93701
        • UCSF Fresno, Clinical Research Center
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • Los Angeles, California, United States, 90057
        • National Research Institute, Wilshire
      • Los Angeles, California, United States, 90067
        • GastroIntestinal BioSciences
      • Los Angeles, California, United States, 90073
        • Veteran Affairs Great Los Angeles Healthcare System
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Diego, California, United States, 92120
        • eStudy Site
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
      • San Francisco, California, United States, 94109
        • California Pacific Medical Center (CPMC)
      • San Francisco, California, United States, 94110
        • UCSF/ San Francisco General Hospital
      • San Jose, California, United States, 95128
        • Silicon Valley Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Hospital
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research, Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Doral, Florida, United States, 33166
        • Integrity Clinical Research, LLC
      • Gainesville, Florida, United States, 32610
        • UF Hepatology Research at CTRB
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32207
        • UF Health Jacksonville-Gastroenterology Emerson
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Digestive Health Specialist Research Institute
      • Lauderdale Lakes, Florida, United States, 33319
        • Sunrise Medical Research, Inc.
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases
      • Miami, Florida, United States, 33125
        • Bruce W. Carter Miami VA Medical Center
      • Miami, Florida, United States, 33175
        • ProLive Medical Research
      • Miami, Florida, United States, 33186
        • Janus Clinical Research, Inc.
      • Ocoee, Florida, United States, 34761
        • Sensible HealthCare, LLC
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Institute
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, P.A.
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Athens, Georgia, United States, 30607
        • Summit Clinical Research, LLC
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic (TEC)
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center - Liver Center
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology & Hepatology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • The Medical Center of Bowling Green
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Medical, Clinical Trials Unit
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Investigative Clinical Research
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates/Center for Digestive Care
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Minnesota Gastroenterology
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research, LLC
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University Gastroenterology & Hepatology
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Gastroenterology
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • CHI Health Alegent Creighton Clinic Gastroenterology
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
      • Martinsville, New Jersey, United States, 08836
        • Amici Clinical Research
      • Martinsville, New Jersey, United States, 08836
        • Amici GI - LLC
      • Newark, New Jersey, United States, 07103
        • Rutgers University New Jersey Medical School
      • Paterson, New Jersey, United States, 07503
        • Saint Joseph's Regional Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • AccumetRx Clinical research / UGNM
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14203
        • University at Buffalo, Clinical and Translational Research Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
      • New York, New York, United States, 10016
        • Concorde Medical Group PLLC
      • New York, New York, United States, 10016
        • New York University (NYU) Langone Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University of North Carolina at Chapel Hill, School of Medicine
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology
      • Charlotte, North Carolina, United States, 28204
        • Center for Liver Disease
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Huntersville, North Carolina, United States, 28078
        • Carolinas Center for Liver Disease/Carolinas HeatlhCare System
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
      • Cincinnati, Ohio, United States, 45267-0595
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43203
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Gastroenterology
      • Flourtown, Pennsylvania, United States, 19031
        • Hillmont GI, pc
      • Hershey, Pennsylvania, United States, 17033
        • The Pennsylvania State University and The Milton S. Hershey Medical Center
      • Lansdale, Pennsylvania, United States, 19446
        • Hillmont G.I. - Lansdale Office
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Healthcare Network
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health- Upstate Gastroenterology and Liver Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-Clinsearch, LLC
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Hermitage, Tennessee, United States, 37076
        • Associates in Gastroenterology, PLC
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions
      • Johnson City, Tennessee, United States, 37604
        • East Tennesse Research Institute
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare, University Hospital
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research, PLLC
      • Nashville, Tennessee, United States, 37205
        • Nashville Gastrointestinal Specialists
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75234
        • Liver Center of Texas
      • Dallas, Texas, United States, 75246
        • Texas Digestive Disease Consultants
      • El Paso, Texas, United States, 79935
        • MedResearch, Inc.
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints Medical Center
      • Fort Worth, Texas, United States, 76104
        • Texas Digestive Disease Consultants
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc.
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas, P.A.
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Ben Taub General Hospital
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition
      • McAllen, Texas, United States, 78504
        • Centex Studies, Inc.
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at The Texas Liver Institute
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Consultants of San Antonio
      • San Marcos, Texas, United States, 78666
        • Texas Digestive Disease Consultants - San Marcos
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center - Smith 2
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC GI
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Clinical Research Services Unit (CRSU)
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98105
        • Liver Institute Northwest
      • Seattle, Washington, United States, 98104
        • Swedish Organ Transplant and Liver Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason - Seattle Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.

  2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or

    Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:

    • Obesity (BMI ≥30 kg/m2)
    • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
    • ALT >1.5× upper limit of normal (ULN).
  3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
  4. Stable body weight.

Exclusion Criteria:

  1. Model for End-stage Liver Disease (MELD) score >12
  2. ALT ≥10× ULN
  3. HbA1c >9.5%
  4. Total bilirubin >1.5 mg/dL
  5. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
  6. History of liver transplant, or current placement on a liver transplant list
  7. Current or history of significant alcohol consumption
  8. Prior or planned ileal resection, or prior or planned bariatric surgery
  9. Histological presence of cirrhosis
  10. History of biliary diversion
  11. Known positivity for human immunodeficiency virus infection.
  12. Acute cholecystitis or acute biliary obstruction.
  13. BMI >45 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mg Obeticholic Acid
10 mg Obeticholic Acid daily for the remainder of the study
Drug: Obeticholic Acid
Experimental: 25 mg Obeticholic Acid
25 mg Obeticholic Acid daily for the remainder of the study
Drug: Obeticholic Acid
Placebo Comparator: Placebo
One tablet daily for the remainder of the study
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
Time Frame: Up to 7 years
All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology.
Up to 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies
Time Frame: Up to 7 years
Fibrosis stage was evaluated by NASH Clinical Research Network (CRN) Fibrosis Staging System as follows: Stage 0: No fibrosis, Stage 1: Perisinusoidal/periportal fibrosis, Stage 1A: Mild, zone 3, perisinusoidal fibrosis, Stage 1B: Moderate, zone 3, perisinusoidal fibrosis, Stage 1C: Portal/periportal fibrosis, Stage 2: Perisinusoidal and portal/periportal fibrosis, Stage 3: Bridging fibrosis and Stage 4: Cirrhosis. No worsening of NASH was defined as no worsening of hepatocellular ballooning, no worsening of lobular inflammation, and no worsening of steatosis. Responders are defined as participants who did not discontinue treatment due to Adverse event (AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct the confidence intervals.
Up to 7 years
Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method
Time Frame: Up to 7 years
Fibrosis stage was evaluated by NASH Clinical Research Network(CRN) Fibrosis Staging System as follows: Stage 0:No fibrosis, Stage 1:Perisinusoidal/periportal fibrosis, Stage 1A:Mild, zone 3, perisinusoidal fibrosis, Stage 1B:Moderate, zone3, perisinusoidal fibrosis, Stage 1C:Portal/periportal fibrosis, Stage 2:Perisinusoidal and portal/periportal fibrosis, Stage 3:Bridging fibrosis and Stage 4:Cirrhosis. Resolution of NASH (Nonalcoholic Steatohepatitis) is defined as absence of fatty liver disease, or presence of simple or isolated steatosis without steatohepatitis, with a NAS(NAFLD Activity Score) of 0 for ballooning and 0 to 1 for inflammation. NAS ranges from 0-12; 0: no features of fatty liver disease and 12: highest degree of fatty liver disease. Higher signify worse symptoms. Responders are who did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct confidence intervals.
Up to 7 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 7 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that either newly appeared, increased in frequency, or worsened in severity following treatment up to 30 days from last dose of permanent investigational product discontinuation. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intercept Pharmaceuticals

Investigators

  • Study Director: Sangeeta Sawhney, MD, Intercept Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2015

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimated)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 5, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 747-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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