Clinical trial NCT02548351: Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non Alcoholic Steatohepatitis (NASH)
Keywords: Non Alcoholic Steatohepatitis, fatty liver disease, NASH
Lead sponsor: Intercept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 2477
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
timeFrame: Up to 7 years
Secondary outcomes:
measure: 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
timeFrame: Up to 7 years
measure: 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
timeFrame: Up to 7 years
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Chandler
country: United States
facility: Institute for Liver Health DBA Arizona Liver Health
state: Arizona
city: Glendale
country: United States
facility: Arizona Liver Health - Glendale
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Clinic - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research Inc.
state: California
city: Chula Vista
country: United States
facility: Precision Research Institute
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Covina
country: United States
facility: Citrus Valley Gastroenterology
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Fresno
country: United States
facility: UCSF Fresno, Clinical Research Center
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: National Research Institute, Wilshire
state: California
city: Los Angeles
country: United States
facility: Gastrointestinal Biosciences
state: California
city: Los Angeles
country: United States
facility: Veteran Affairs Great Los Angeles Healthcare System
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: eStudy Site
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center (CPMC)
state: California
city: San Francisco
country: United States
facility: UCSF/ San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Jose
country: United States
facility: Silicon Valley Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Denver and Hospital
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc.
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: UF Hepatology Research at CTRB
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville-Gastroenterology Emerson
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Digestive Health Specialist Research Institute
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Bruce W. Carter Miami VA Medical Center
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research
state: Florida
city: Miami
country: United States
facility: Janus Clinical Research, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant Institute
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, P.A.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Athens
country: United States
facility: Summit Clinical Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic (TEC)
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center - Liver Center
state: Hawaii
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology & Hepatology
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Bowling Green
country: United States
facility: The Medical Center of Bowling Green
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Medical, Clinical Trials Unit
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates/Center for Digestive Care
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research, LLC
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Gastroenterology & Hepatology
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Gastroenterology
state: Missouri
city: Omaha
country: United States
facility: CHI Health Alegent Creighton Clinic Gastroenterology
state: Nebraska
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Martinsville
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Martinsville
country: United States
facility: Amici GI - LLC
state: New Jersey
city: Newark
country: United States
facility: Rutgers University New Jersey Medical School
state: New Jersey
city: Paterson
country: United States
facility: Saint Joseph's Regional Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: AccumetRx Clinical research / UGNM
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo, Clinical and Translational Research Center
state: New York
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Concorde Medical Group PLLC
state: New York
city: New York
country: United States
facility: New York University (NYU) Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Center for Liver Disease
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas Center for Liver Disease/Carolinas HeatlhCare System
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Doylestown
country: United States
facility: Doylestown Health Gastroenterology
state: Pennsylvania
city: Flourtown
country: United States
facility: Hillmont GI, pc
state: Pennsylvania
city: Hershey
country: United States
facility: The Pennsylvania State University and The Milton S. Hershey Medical Center
state: Pennsylvania
city: Lansdale
country: United States
facility: Hillmont G.I. - Lansdale Office
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Healthcare Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health- Upstate Gastroenterology and Liver Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology, PLC
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Johnson City
country: United States
facility: East Tennesse Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Methodist Healthcare, University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: MedResearch, Inc.
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Consultants of San Antonio
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants - San Marcos
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center - Smith 2
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC GI
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason - Seattle Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Organ Transplant and Liver Center
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Gastroenterology and Hepatology Dept.
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Camperdown
country: Australia
facility: AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Kingswood
country: Australia
facility: Nepean Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital, Department of Gastroenterology
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin I Innsbruck
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Brussels
country: Belgium
facility: ULB Hȏpital Erasme - Gastroenterology
state: Brabant
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gathuisberg Hepatology Department
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge Oostende
city: Brussels
country: Belgium
facility: UCL Saint-Luc - Hepatology Department
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
city: Ghent
country: Belgium
facility: UZ Gent Gastroenterology Department
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: London
country: Canada
facility: London Health Sciences Centre University Hospital
state: Ontario
city: Calgary
country: Canada
facility: University of Calgary Liver Unit
city: Edmonton
country: Canada
facility: GI Research
city: Edmonton
country: Canada
facility: University of Alberta
city: Montreal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
city: Montreal
country: Canada
facility: The Research Institute of the McGill University Health Centre
city: Toronto
country: Canada
facility: Toronto Center for Liver Disease
city: Toronto
country: Canada
facility: Toronto Liver Centre
city: Vancouver
country: Canada
facility: LAIR Centre
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
city: Vancouver
country: Canada
facility: GIRI - GI Research Institute
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
city: Winnipeg
country: Canada
facility: John Buhler Research Centre
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers-Service d'Hepato-Gastroenterologie
city: Bourgoin-Jallieu
country: France
facility: Centre hospitalier Pierre Oudot
city: Clichy
country: France
facility: CHU Beaujon-Service d'Hépatologie
city: Creteil
country: France
facility: Hôpital Henri Mondor - Service d'hépatologie
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU Hôpital Claude Huriez
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Nice
country: France
facility: Hôpital de l'Archet II-CHU Nice
city: Orléans
country: France
facility: Service d'Hepato-Gastroenterologie CHR Orleans - La Source
city: Paris
country: France
facility: Hospital Saint Antoine Department of Hepatology
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrère
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac
country: France
facility: Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: CHU Toulouse - Hopital de Purpan
city: Vandoeuvre-Lès-Nancy
country: France
facility: CHU de Nancy - Hôpital de Brabois adultes
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1
state: Bavaria
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie
state: Saxony
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Campus Virchow
city: Bochum
country: Germany
facility: St. Josef-Hospital, Ruhr University Bochum
city: Cologne
country: Germany
facility: University Hosptial Cologne Clinics for Gastroenterology and Hepatology
city: Essen
country: Germany
facility: University Hospital Essen
city: Essen
country: Germany
facility: Katholische Kliniken Ruhrhalbinsel GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg- Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis
city: Kiel
country: Germany
facility: Hepato-Gastroenterology Center Kiel
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Munich
country: Germany
facility: Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan és Szent Laszlo
city: Budapest
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz
city: Debrecen
country: Hungary
facility: Kenezy Gyula Korhaz es Rendelointezet
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center Division of Internal Medicine
city: Haifa
country: Israel
facility: Rambam Medical Center Center for Liver diseases
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaarei Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem MC
city: Nahariya
country: Israel
facility: West Galilee Hospital
city: Nazareth
country: Israel
facility: Holy Family Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Liver Institute
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Tel-Aviv Medical Center
city: Bologna
country: Italy
facility: Universita di Bologna - DIMEC
city: Bologna
country: Italy
facility: University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale
city: Milano
country: Italy
facility: Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Grande Ospedale
city: Milan
country: Italy
facility: Ospedale san Giuseppe - Multimedica
city: Modena
country: Italy
facility: AOU di Modena Ospedale Civile
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico
city: Palermo
country: Italy
facility: Policlinico Paolo Giaccone di Palermo
city: Rome
country: Italy
facility: Policlinico University Campus Biomedico
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
city: Grafton
country: New Zealand
facility: NZ Liver Transplant Unit
state: Auckland
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga, E.P.E.
city: Beja
country: Portugal
facility: Ulsba, Epe
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira - Guimarães
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group, LLC
city: San Juan
country: Puerto Rico
facility: Ave Ponce De Leon #715
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion
city: Belgrade
country: Serbia
facility: University Medical Centar Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Baleares
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcon
city: Alicante
country: Spain
facility: Hospital General y Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar Gastroenterology Department
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic(o) de Barcelona
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital (Universitario) Virgen de la Victoria
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
city: Santander
country: Spain
facility: Hospital (Universitario) Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario
city: Valencia
country: Spain
facility: Hospital Universitario La Fe.
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: Universitetsjukhuset Linkoping
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Bern
country: Switzerland
facility: UVCM Hepatologie
city: Lugano
country: Switzerland
facility: Epatocentro Ticino
city: St.Gallen
country: Switzerland
facility: Hospital of St. Gallen
city: Zürich
country: Switzerland
facility: University Clinic of Gastroenterology & Hepatology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals
state: Norfolk
city: Headington
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxford
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
state: Surrey
city: Birmingham
country: United Kingdom
facility: Institute of Biomedical Research
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: University Hospital Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary, NHS Greater
city: Hull
country: United Kingdom
facility: Gastroenterology Department Hull Royal Infirmary
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: Institute for Liver and Digestive Health
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham Digestive Diseases and Biomedical Research Unit
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Intercept Pharmaceuticals
name: Sangeeta Sawhney, MD
role: STUDY_DIRECTOR
References:
citation: Rinella 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.
citation: Younossi 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.
citation: Younossi 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.
citation: Ratziu 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.