Study Stopped
The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. Sponsor decided to terminate 747-303 before the planned completion date.
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
REGENERATE
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
1 other identifier
interventional
2,477
19 countries
331
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Longer than P75 for phase_3
331 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedStudy Start
First participant enrolled
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedResults Posted
Study results publicly available
September 5, 2024
CompletedOctober 1, 2024
September 1, 2024
8 years
September 1, 2015
August 14, 2024
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
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 Outcomes (3)
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
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
Up to 7 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 7 years
Study Arms (3)
10 mg Obeticholic Acid
EXPERIMENTAL10 mg Obeticholic Acid daily for the remainder of the study
25 mg Obeticholic Acid
EXPERIMENTAL25 mg Obeticholic Acid daily for the remainder of the study
Placebo
PLACEBO COMPARATOROne tablet daily for the remainder of the study
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- 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.
- Stable body weight.
You may not qualify if:
- Model for End-stage Liver Disease (MELD) score \>12
- ALT ≥10× ULN
- HbA1c \>9.5%
- Total bilirubin \>1.5 mg/dL
- 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)
- History of liver transplant, or current placement on a liver transplant list
- Current or history of significant alcohol consumption
- Prior or planned ileal resection, or prior or planned bariatric surgery
- Histological presence of cirrhosis
- History of biliary diversion
- Known positivity for human immunodeficiency virus infection.
- Acute cholecystitis or acute biliary obstruction.
- BMI \>45 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (346)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Institute for Liver Health DBA Arizona Liver Health
Chandler, Arizona, 85224, United States
Arizona Liver Health - Glendale
Glendale, Arizona, 85306, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Arizona Liver Clinic - Tucson
Tucson, Arizona, 85711, United States
Liver Wellness Center
Little Rock, Arkansas, 72205, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
GW Research Inc.
Chula Vista, California, 91910, United States
Precision Research Institute
Chula Vista, California, 91910, United States
Southern California Research Center
Coronado, California, 92118, United States
Citrus Valley Gastroenterology
Covina, California, 91722, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
UCSF Fresno, Clinical Research Center
Fresno, California, 93701, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California, San Diego
La Jolla, California, 92037, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
National Research Institute, Wilshire
Los Angeles, California, 90057, United States
Gastrointestinal Biosciences
Los Angeles, California, 90067, United States
Veteran Affairs Great Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Stanford University
Palo Alto, California, 94304, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
eStudy Site
San Diego, California, 92120, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
California Pacific Medical Center (CPMC)
San Francisco, California, 94109, United States
UCSF/ San Francisco General Hospital
San Francisco, California, 94110, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Silicon Valley Research Institute
San Jose, California, 95128, United States
University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
UF Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
UF Health Jacksonville-Gastroenterology Emerson
Jacksonville, Florida, 32207, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Digestive Health Specialist Research Institute
Lakewood Rch, Florida, 34211, United States
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida, 33319, United States
Meridien Research
Maitland, Florida, 32751, United States
Bruce W. Carter Miami VA Medical Center
Miami, Florida, 33125, United States
Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
ProLive Medical Research
Miami, Florida, 33175, United States
Janus Clinical Research, Inc.
Miami, Florida, 33186, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Florida Hospital Transplant Institute
Orlando, Florida, 32804, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, 33414, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Summit Clinical Research, LLC
Athens, Georgia, 30607, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
The Emory Clinic (TEC)
Atlanta, Georgia, 30322, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
The Queen's Medical Center - Liver Center
Honolulu, Hawaii, 96813, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology & Hepatology
Indianapolis, Indiana, 46237, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
The Medical Center of Bowling Green
Bowling Green, Kentucky, 42101, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
University of Louisville Medical, Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research
Wyoming, Michigan, 49519, United States
Huron Gastroenterology Associates/Center for Digestive Care
Ypsilanti, Michigan, 48197, United States
Minnesota Gastroenterology
Minneapolis, Minnesota, 55413, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Southern Therapy and Advanced Research, LLC
Jackson, Mississippi, 39216, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Saint Louis University Gastroenterology & Hepatology
St Louis, Missouri, 63104, United States
Washington University School of Medicine - Gastroenterology
St Louis, Missouri, 63110, United States
CHI Health Alegent Creighton Clinic Gastroenterology
Omaha, Nebraska, 68124, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Amici Clinical Research
Martinsville, New Jersey, 08836, United States
Amici GI - LLC
Martinsville, New Jersey, 08836, United States
Rutgers University New Jersey Medical School
Newark, New Jersey, 07103, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
AccumetRx Clinical research / UGNM
Albuquerque, New Mexico, 87109, United States
University at Buffalo, Clinical and Translational Research Center
Buffalo, New York, 14203, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Concorde Medical Group PLLC
New York, New York, 10016, United States
New York University (NYU) Langone Medical Center
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill, School of Medicine
Chapel Hill, North Carolina, 27599-7584, United States
Center for Liver Disease
Charlotte, North Carolina, 28204, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Carolinas Center for Liver Disease/Carolinas HeatlhCare System
Huntersville, North Carolina, 28078, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45249, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0595, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43203, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Doylestown Health Gastroenterology
Doylestown, Pennsylvania, 18901, United States
Hillmont GI, pc
Flourtown, Pennsylvania, 19031, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hillmont G.I. - Lansdale Office
Lansdale, Pennsylvania, 19446, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Prisma Health- Upstate Gastroenterology and Liver Center
Greenville, South Carolina, 29605, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Associates in Gastroenterology, PLC
Hermitage, Tennessee, 37076, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
East Tennesse Research Institute
Johnson City, Tennessee, 37604, United States
Methodist Healthcare, University Hospital
Memphis, Tennessee, 38104, United States
Nashville Gastrointestinal Specialists
Nashville, Tennessee, 37205, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Liver Center of Texas
Dallas, Texas, 75234, United States
Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MedResearch, Inc.
El Paso, Texas, 79935, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104, United States
Texas Digestive Disease Consultants
Fort Worth, Texas, 76104, United States
Baylor College of Medicine Ben Taub General Hospital
Houston, Texas, 77030, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition
Houston, Texas, 77030, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Centex Studies, Inc.
McAllen, Texas, 78504, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
Gastroenterology Consultants of San Antonio
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
The University of Vermont Medical Center - Smith 2
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226, United States
McGuire DVAMC GI
Richmond, Virginia, 23249, United States
Virginia Commonwealth University Clinical Research Services Unit (CRSU)
Richmond, Virginia, 23298, United States
Virginia Mason - Seattle Medical Center
Seattle, Washington, 98101, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
Liver Institute Northwest
Seattle, Washington, 98105, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705, United States
Royal Adelaide Hospital Gastroenterology and Hepatology Dept.
Adelaide, 5000, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Monash Health - Monash Medical Centre
Clayton, 3168, Australia
Gallipoli Medical Research Foundation
Greenslopes, 4120, Australia
Austin Hospital
Heidelberg, 3084, Australia
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
Nepean Hospital
Kingswood, 2747, Australia
The Alfred Hospital, Department of Gastroenterology
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
The Royal Melbourne Hospital
Parkville, 3053, Australia
Westmead Hospital
Westmead, 2145, Australia
Universitätsklinik für Innere Medizin I Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
Ordensklinikum Linz GmbH
Linz, 4010, Austria
Uniklinikum Salzburg
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
ULB Hȏpital Erasme - Gastroenterology
Brussels, Brabant, 1070, Belgium
UZ Leuven Campus Gathuisberg Hepatology Department
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Sint-Jan Brugge Oostende
Bruges, B-8000, Belgium
UCL Saint-Luc - Hepatology Department
Brussels, 1200, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600, Belgium
UZ Gent Gastroenterology Department
Ghent, 9000, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
London Health Sciences Centre University Hospital
London, Ontario, N6A 5A5, Canada
University of Calgary Liver Unit
Calgary, T2N 4Z6, Canada
GI Research
Edmonton, T5H 4B9, Canada
University of Alberta
Edmonton, T6G 2X8, Canada
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
Montreal, H2X 0A9, Canada
The Research Institute of the McGill University Health Centre
Montreal, H4A 3J1, Canada
Toronto Center for Liver Disease
Toronto, M5G 2C4, Canada
Toronto Liver Centre
Toronto, M6H 3M1, Canada
LAIR Centre
Vancouver, V5Z 1H3, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, V5Z 1M9, Canada
GIRI - GI Research Institute
Vancouver, V6Z 2K5, Canada
PerCuro Clinical Research Ltd.
Victoria, V8V 3M9, Canada
John Buhler Research Centre
Winnipeg, R3E 3P4, Canada
Aalborg University Hospital
Aalborg, 9001, Denmark
Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling
Aarhus, 8200, Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, 2650, Denmark
Odense University Hospital
Odense, 5000, Denmark
Helsinki University Hospital
Helsinki, 00290, Finland
Turku University Hospital
Turku, 20520, Finland
CHU Amiens Picardie
Amiens, 80054, France
CHU Angers-Service d'Hepato-Gastroenterologie
Angers, 49933, France
Centre hospitalier Pierre Oudot
Bourgoin, 38300, France
CHU Beaujon-Service d'Hépatologie
Clichy, 92110, France
Hôpital Henri Mondor - Service d'hépatologie
Créteil, 94000, France
CHU Grenoble
Grenoble, 38700, France
CHRU Hôpital Claude Huriez
Lille, 59037, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Hôpital Saint Joseph
Marseille, 13008, France
Hôpital de l'Archet II-CHU Nice
Nice, 6202, France
Service d'Hepato-Gastroenterologie CHR Orleans - La Source
Orléans, 45100, France
Hospital Saint Antoine Department of Hepatology
Paris, 75012, France
Hôpital de la Pitié Salpétrère
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN
Pessac, 33604, France
CHU de Rouen
Rouen, 76031, France
CHU Toulouse - Hopital de Purpan
Toulouse, 31059, France
CHU de Nancy - Hôpital de Brabois adultes
Vandœuvre-lès-Nancy, 54500, France
Hopital Paul Brousse
Villejuif, 94804, France
Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie
Heidelberg, Baden-Wurttemberg, 69120, Germany
Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1
Erlangen, Bavaria, 91054, Germany
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
Mainz, Rhineland-Palatinate, 55131, Germany
Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie
Leipzig, Saxony, 04103, Germany
Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III
Aachen, 52074, Germany
Charite Universitätsmedizin Campus Virchow
Berlin, 13353, Germany
St. Josef-Hospital, Ruhr University Bochum
Bochum, 44791, Germany
University Hosptial Cologne Clinics for Gastroenterology and Hepatology
Cologne, 50937, Germany
University Hospital Essen
Essen, 45147, Germany
Katholische Kliniken Ruhrhalbinsel GmbH
Essen, 45257, Germany
Universitätsklinikum Hamburg- Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Gastroenterologische Gemeinschaftspraxis
Herne, 44623, Germany
Hepato-Gastroenterology Center Kiel
Kiel, 24146, Germany
EUGASTRO GmbH
Leipzig, 04103, Germany
Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie
Munich, 80639, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Egyesitett Szent Istvan és Szent Laszlo
Budapest, 1097, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz
Budapest, 7624, Hungary
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, 4031, Hungary
Soroka Medical Center Division of Internal Medicine
Beersheba, 84101, Israel
Rambam Medical Center Center for Liver diseases
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Shaarei Zedek Medical Center
Jerusalem, 03235, Israel
Hadassah Ein Kerem MC
Jerusalem, 91120, Israel
West Galilee Hospital
Nahariya, 22100, Israel
Holy Family Medical Center
Nazareth, 16100, Israel
Rabin Medical Center, Liver Institute
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Sourasky Tel-Aviv Medical Center
Tel Aviv, 64239, Israel
Universita di Bologna - DIMEC
Bologna, 40138, Italy
University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC
Bologna, 40138, Italy
Ospedale san Giuseppe - Multimedica
Milan, 20123, Italy
Fondazione IRCCS Ca Granda Ospedale
Milan, 20122, Italy
Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo
Milan, 20142, Italy
Fondazione IRCCS Ca Grande Ospedale
Milan, Italy
AOU di Modena Ospedale Civile
Modena, 41126, Italy
Azienda Ospedaliera Universitaria Policlinico
Napoli, 80131, Italy
Policlinico Paolo Giaccone di Palermo
Palermo, 90127, Italy
Policlinico University Campus Biomedico
Rome, 00128, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126, Italy
NZ Liver Transplant Unit
Grafton, Auckland, 1023, New Zealand
Middlemore Hospital
Auckland, 2025, New Zealand
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546, Poland
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-752, Poland
Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego
Lodz, 91-347, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081, Poland
Centrum Badan Klinicznych Piotr Napora
Wroclaw, 51-349, Poland
Centro Hospitalar do Baixo Vouga, E.P.E.
Aveiro, 3814-201, Portugal
Ulsba, Epe
Beja, 7801-849, Portugal
Hospital da Senhora da Oliveira - Guimarães
Guimarães, 4835-044, Portugal
Centro Hospitalar Lisboa Ocidental
Lisbon, 1349-019, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria
Lisbon, 1649-035, Portugal
Klinical Investigations Group, LLC
San Juan, 00909, Puerto Rico
Ave Ponce De Leon #715
San Juan, 00918, Puerto Rico
Fundacion de Investigacion
San Juan, 00927, Puerto Rico
University Medical Centar Zvezdara
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Fundación Alcorcon
Alcorcón, 28922, Spain
Hospital General y Universitario de Alicante
Alicante, 03010, Spain
Hospital del Mar Gastroenterology Department
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic(o) de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, 20014, Spain
Complejo Asistencial Universitario de Leon
León, 24071, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital (Universitario) Virgen de la Victoria
Málaga, 29010, Spain
Hospital (Universitario) Marqués de Valdecilla
Santander, 39008, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Consorcio Hospital General Universitario
Valencia, 46014, Spain
Hospital Universitario La Fe.
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Sahlgrenska University Hospital
Gothenburg, SE-413 45, Sweden
Universitetsjukhuset Linkoping
Linköping, SE-581 85, Sweden
Karolinska University Hospital
Stockholm, SE-141 86, Sweden
UVCM Hepatologie
Bern, 3010, Switzerland
Epatocentro Ticino
Lugano, 6900, Switzerland
Hospital of St. Gallen
Sankt Gallen, 9007, Switzerland
University Clinic of Gastroenterology & Hepatology
Zurich, 8091, Switzerland
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Norfolk and Norwich University Hospitals
Norwich, Norfolk, NR4 7UY, United Kingdom
John Radcliffe Hospital
Headington, Oxford, OX3 9DU, United Kingdom
Royal Surrey NHS Foundation Trust
Guildford, Surrey, GU27XX, United Kingdom
Institute of Biomedical Research
Birmingham, B15 2TT, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8HW, United Kingdom
Cambridge University Hospital
Cambridge, CB2 0QQ, United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, CV2 2DX, United Kingdom
Glasgow Royal Infirmary, NHS Greater
Glasgow, G4 0SF, United Kingdom
Gastroenterology Department Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
Royal London Hospital
London, E1 1FR, United Kingdom
Institute for Liver and Digestive Health
London, NW3 2QG, United Kingdom
Guy's and St. Thomas NHS Foundation Trust
London, SE1 9RT, United Kingdom
St. Mary's Hospital
London, W2 1NY, United Kingdom
Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham Digestive Diseases and Biomedical Research Unit
Nottingham, NG7 2UH, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Related Publications (5)
Sanyal AJ, Loomba R, Anstee QM, Ratziu V, Kowdley KV, Rinella ME, Harrison SA, Resnick MB, Capozza T, Sawhney S, Shelat N, Younossi ZM. Utility of pathologist panels for achieving consensus in NASH histologic scoring in clinical trials: Data from a phase 3 study. Hepatol Commun. 2023 Dec 22;8(1):e0325. doi: 10.1097/HC9.0000000000000325. eCollection 2024 Jan 1.
PMID: 38126958DERIVEDRinella ME, Dufour JF, Anstee QM, Goodman Z, Younossi Z, Harrison SA, Loomba R, Sanyal AJ, Bonacci M, Trylesinski A, Natha M, Shringarpure R, Granston T, Venugopal A, Ratziu V. Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study. J Hepatol. 2022 Mar;76(3):536-548. doi: 10.1016/j.jhep.2021.10.029. Epub 2021 Nov 15.
PMID: 34793868DERIVEDYounossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2050-2058.e12. doi: 10.1016/j.cgh.2021.07.020. Epub 2021 Jul 15.
PMID: 34274514DERIVEDYounossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5.
PMID: 31813633DERIVEDRatziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.
PMID: 31260793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Intercept Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Sangeeta Sawhney, MD
Intercept Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 14, 2015
Study Start
September 22, 2015
Primary Completion
September 15, 2023
Study Completion
September 15, 2023
Last Updated
October 1, 2024
Results First Posted
September 5, 2024
Record last verified: 2024-09