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

Primary Purpose

Non Alcoholic Steatohepatitis (NASH)

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obeticholic Acid
Placebo
Sponsored by
Intercept Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis (NASH) focused on measuring Non Alcoholic Steatohepatitis, fatty liver disease, NASH

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham
  • Digestive Health Specialists of the Southeast
  • Institute for Liver Health DBA Arizona Liver Health
  • Arizona Liver Health - Glendale
  • St. Joseph's Hospital and Medical Center
  • Mayo Clinic Arizona
  • Arizona Liver Clinic - Tucson
  • Liver Wellness Center
  • Arkansas Gastroenterology
  • GW Research Inc.
  • Precision Research Institute
  • Southern California Research Center
  • Citrus Valley Gastroenterology
  • TriWest Research Associates, LLC
  • UCSF Fresno, Clinical Research Center
  • Fresno Clinical Research Center
  • Scripps Clinic
  • University of California, San Diego
  • Keck Medical Center of USC
  • Cedars-Sinai Medical Center
  • National Research Institute, Wilshire
  • Gastrointestinal Biosciences
  • Veteran Affairs Great Los Angeles Healthcare System
  • Stanford University
  • Inland Empire Liver Foundation
  • University of California Davis Medical Center
  • eStudy Site
  • Medical Associates Research Group
  • Kaiser Permanente
  • California Pacific Medical Center (CPMC)
  • UCSF/ San Francisco General Hospital
  • Quest Clinical Research
  • University of California, San Francisco
  • Silicon Valley Research Institute
  • University of Colorado Denver and Hospital
  • South Denver Gastroenterology, PC
  • Western States Clinical Research, Inc.
  • Yale University School of Medicine
  • Integrity Clinical Research, LLC
  • UF Hepatology Research at CTRB
  • Nature Coast Clinical Research
  • UF Health Jacksonville-Gastroenterology Emerson
  • Mayo Clinic
  • Florida Digestive Health Specialist Research Institute
  • Sunrise Medical Research, Inc.
  • Meridien Research
  • Bruce W. Carter Miami VA Medical Center
  • Schiff Center for Liver Diseases
  • ProLive Medical Research
  • Janus Clinical Research, Inc.
  • Sensible Healthcare, LLC
  • Florida Hospital Transplant Institute
  • South Florida Center of Gastroenterology, P.A.
  • Florida Medical Clinic, P.A.
  • Summit Clinical Research, LLC
  • Digestive Healthcare of Georgia
  • Piedmont Atlanta Hospital
  • The Emory Clinic (TEC)
  • Gastrointestinal Specialists of Georgia
  • The Queen's Medical Center - Liver Center
  • Grand Teton Research Group
  • Northwestern University, Feinberg School of Medicine
  • The University of Chicago Medical Center
  • Loyola University Medical Center
  • Indiana University Health University Hospital
  • Indianapolis Gastroenterology & Hepatology
  • The University of Kansas Medical Center
  • The Medical Center of Bowling Green
  • University of Kentucky Chandler Medical Center
  • University of Louisville Medical, Clinical Trials Unit
  • Tulane Medical Center
  • Ochsner Clinic Foundation
  • Louisiana Research Center, LLC
  • Investigative Clinical Research
  • Mercy Medical Center
  • Johns Hopkins Hospital
  • Walter Reed National Military Medical Center
  • Massachusetts General Hospital
  • Boston Medical Center
  • Beth Israel Deaconess Medical Center
  • Lahey Hospital & Medical Center
  • University of Massachusetts Medical School
  • Henry Ford Health System
  • Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research
  • Huron Gastroenterology Associates/Center for Digestive Care
  • Minnesota Gastroenterology
  • Mayo Clinic
  • Southern Therapy and Advanced Research, LLC
  • Kansas City VA Medical Center
  • Kansas City Research Institute
  • Saint Louis University Gastroenterology & Hepatology
  • Washington University School of Medicine - Gastroenterology
  • CHI Health Alegent Creighton Clinic Gastroenterology
  • AGA Clinical Research Associates, LLC
  • Amici Clinical Research
  • Amici GI - LLC
  • Rutgers University New Jersey Medical School
  • Saint Joseph's Regional Medical Center
  • AccumetRx Clinical research / UGNM
  • Montefiore Medical Center
  • University at Buffalo, Clinical and Translational Research Center
  • Mount Sinai Beth Israel
  • Concorde Medical Group PLLC
  • New York University (NYU) Langone Medical Center
  • Weill Cornell Medical College
  • Icahn School of Medicine at Mt. Sinai
  • Columbia University Medical Center
  • University of Rochester Medical Center
  • Asheville Gastroenterology Associates, PA
  • University of North Carolina at Chapel Hill, School of Medicine
  • Center for Liver Disease
  • Charlotte Gastroenterology & Hepatology
  • Duke University Medical Center
  • Cumberland Research Associates, LLC
  • Carolinas Center for Liver Disease/Carolinas HeatlhCare System
  • Digestive Health Specialists, PA
  • Consultants for Clinical Research
  • University of Cincinnati
  • University Hospitals Case Medical Center
  • MetroHealth Medical Center
  • The Ohio State University Wexner Medical Center
  • INTEGRIS Baptist Medical Center
  • Doylestown Health Gastroenterology
  • Hillmont GI, pc
  • The Pennsylvania State University and The Milton S. Hershey Medical Center
  • Hillmont G.I. - Lansdale Office
  • Drexel University
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University
  • Einstein Healthcare Network
  • UPMC
  • University Gastroenterology
  • Prisma Health- Upstate Gastroenterology and Liver Center
  • Rapid City Medical Center
  • WR-Clinsearch, LLC
  • Gastro One
  • Associates in Gastroenterology, PLC
  • Clinical Research Solutions
  • East Tennesse Research Institute
  • Methodist Healthcare, University Hospital
  • Nashville Gastrointestinal Specialists
  • Quality Medical Research, PLLC
  • Vanderbilt University Medical Center
  • Texas Clinical Research Institute
  • The Liver Institute at Methodist Dallas Medical Center
  • Liver Center of Texas
  • Texas Digestive Disease Consultants
  • UT Southwestern Medical Center
  • MedResearch, Inc.
  • Brooke Army Medical Center
  • Baylor Scott & White All Saints Medical Center
  • Texas Digestive Disease Consultants
  • Baylor College of Medicine Ben Taub General Hospital
  • Baylor College of Medicine
  • Houston Methodist Hospital
  • Liver Associates of Texas, P.A.
  • The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition
  • Centex Studies, Inc.
  • Centex Studies, Inc.
  • American Research Corporation at the Texas Liver Institute
  • Gastroenterology Consultants of San Antonio
  • Texas Digestive Disease Consultants - San Marcos
  • University of Utah Hospital
  • The University of Vermont Medical Center - Smith 2
  • University of Virginia Health System
  • Inova Fairfax Medical Campus
  • Digestive and Liver Disease Specialists
  • Bon Secours St. Mary's Hospital
  • McGuire DVAMC GI
  • Virginia Commonwealth University Clinical Research Services Unit (CRSU)
  • Virginia Mason - Seattle Medical Center
  • Swedish Organ Transplant and Liver Center
  • Liver Institute Northwest
  • University of Washington Medical Center
  • University of Wisconsin Hospital & Clinics
  • Royal Adelaide Hospital Gastroenterology and Hepatology Dept.
  • Flinders Medical Centre
  • AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital
  • Monash Health - Monash Medical Centre
  • Gallipoli Medical Research Foundation
  • Austin Hospital
  • Royal Brisbane and Women's Hospital
  • Nepean Hospital
  • The Alfred Hospital, Department of Gastroenterology
  • Fiona Stanley Hospital
  • The Royal Melbourne Hospital
  • Westmead Hospital
  • Universitätsklinik für Innere Medizin I Innsbruck
  • Klinikum Klagenfurt am Wörthersee
  • Ordensklinikum Linz GmbH
  • Uniklinikum Salzburg
  • Medizinische Universität Wien
  • UZ Antwerpen
  • ULB Hȏpital Erasme - Gastroenterology
  • UZ Leuven Campus Gathuisberg Hepatology Department
  • AZ Sint-Jan Brugge Oostende
  • UCL Saint-Luc - Hepatology Department
  • Ziekenhuis Oost-Limburg (ZOL)
  • UZ Gent Gastroenterology Department
  • AZ Nikolaas
  • London Health Sciences Centre University Hospital
  • University of Calgary Liver Unit
  • GI Research
  • University of Alberta
  • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
  • The Research Institute of the McGill University Health Centre
  • Toronto Center for Liver Disease
  • Toronto Liver Centre
  • LAIR Centre
  • Gordon and Leslie Diamond Health Care Centre
  • GIRI - GI Research Institute
  • PerCuro Clinical Research Ltd.
  • John Buhler Research Centre
  • Aalborg University Hospital
  • Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling
  • Copenhagen University Hospital Hvidovre
  • Odense University Hospital
  • Helsinki University Hospital
  • Turku University Hospital
  • CHU Amiens Picardie
  • CHU Angers-Service d'Hepato-Gastroenterologie
  • Centre hospitalier Pierre Oudot
  • CHU Beaujon-Service d'Hépatologie
  • Hôpital Henri Mondor - Service d'hépatologie
  • CHU Grenoble
  • CHRU Hôpital Claude Huriez
  • Hôpital de la Croix Rousse
  • Hôpital Saint Joseph
  • Hôpital de l'Archet II-CHU Nice
  • Service d'Hepato-Gastroenterologie CHR Orleans - La Source
  • Hospital Saint Antoine Department of Hepatology
  • Hôpital de la Pitié Salpétrère
  • Hôpital Cochin
  • Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN
  • CHU de Rouen
  • CHU Toulouse - Hopital de Purpan
  • CHU de Nancy - Hôpital de Brabois adultes
  • Hopital Paul Brousse
  • Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie
  • Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1
  • Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
  • Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie
  • Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III
  • Charite Universitätsmedizin Campus Virchow
  • St. Josef-Hospital, Ruhr University Bochum
  • University Hosptial Cologne Clinics for Gastroenterology and Hepatology
  • University Hospital Essen
  • Katholische Kliniken Ruhrhalbinsel GmbH
  • Universitätsklinikum Hamburg- Eppendorf
  • Medizinische Hochschule Hannover
  • Gastroenterologische Gemeinschaftspraxis
  • Hepato-Gastroenterology Center Kiel
  • EUGASTRO GmbH
  • Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie
  • Universitätsklinikum Würzburg
  • Egyesitett Szent Istvan és Szent Laszlo
  • Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz
  • Kenezy Gyula Korhaz es Rendelointezet
  • Soroka Medical Center Division of Internal Medicine
  • Rambam Medical Center Center for Liver diseases
  • Carmel Medical Center
  • Shaarei Zedek Medical Center
  • Hadassah Ein Kerem MC
  • West Galilee Hospital
  • Holy Family Medical Center
  • Rabin Medical Center, Liver Institute
  • Sheba Medical Center
  • Sourasky Tel-Aviv Medical Center
  • Universita di Bologna - DIMEC
  • University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC
  • Fondazione IRCCS Ca Granda Ospedale
  • Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo
  • Fondazione IRCCS Ca Grande Ospedale
  • Ospedale san Giuseppe - Multimedica
  • AOU di Modena Ospedale Civile
  • Azienda Ospedaliera Universitaria Policlinico
  • Policlinico Paolo Giaccone di Palermo
  • Policlinico University Campus Biomedico
  • Istituto Clinico Humanitas
  • A.O.U. Città della Salute e della Scienza di Torino
  • NZ Liver Transplant Unit
  • Middlemore Hospital
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Centrum Badan Klinicznych Piotr Napora
  • Centro Hospitalar do Baixo Vouga, E.P.E.
  • Ulsba, Epe
  • Hospital da Senhora da Oliveira - Guimarães
  • Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria
  • Centro Hospitalar Lisboa Ocidental
  • Klinical Investigations Group, LLC
  • Ave Ponce De Leon #715
  • Fundacion de Investigacion
  • University Medical Centar Zvezdara
  • Clinical Hospital Center Bezanijska Kosa
  • Clinical Center Nis
  • Hospital Universitari Son Espases
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario Fundación Alcorcon
  • Hospital General y Universitario de Alicante
  • Hospital del Mar Gastroenterology Department
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic(o) de Barcelona
  • Complejo Asistencial Universitario de Leon
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario La Paz
  • Hospital (Universitario) Virgen de la Victoria
  • Hospital Universitario Donostia
  • Hospital (Universitario) Marqués de Valdecilla
  • Hospital Clinico Universitario de Santiago
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Consorcio Hospital General Universitario
  • Hospital Universitario La Fe.
  • Hospital Universitario Miguel Servet
  • Sahlgrenska University Hospital
  • Universitetsjukhuset Linkoping
  • Karolinska University Hospital
  • UVCM Hepatologie
  • Epatocentro Ticino
  • Hospital of St. Gallen
  • University Clinic of Gastroenterology & Hepatology
  • Royal Cornwall Hospital
  • Royal Bournemouth Hospital
  • Queen Alexandra Hospital
  • Norfolk and Norwich University Hospitals
  • John Radcliffe Hospital
  • Royal Surrey NHS Foundation Trust
  • Institute of Biomedical Research
  • Bradford Royal Infirmary
  • University Hospital Bristol NHS Foundation Trust
  • Cambridge University Hospital
  • University Hospitals Coventry & Warwickshire
  • Glasgow Royal Infirmary, NHS Greater
  • Gastroenterology Department Hull Royal Infirmary
  • University Hospital Aintree
  • Royal London Hospital
  • Institute for Liver and Digestive Health
  • Guy's and St. Thomas NHS Foundation Trust
  • St. Mary's Hospital
  • Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Nottingham Digestive Diseases and Biomedical Research Unit
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

10 mg Obeticholic Acid

25 mg Obeticholic Acid

Placebo

Arm Description

10 mg Obeticholic Acid daily for the remainder of the study

25 mg Obeticholic Acid daily for the remainder of the study

One tablet daily for the remainder of the study

Outcomes

Primary Outcome Measures

To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with stage 2 or 3 fibrosis by assessing the following primary endpoints
Primary endpoints include: The proportion of Obeticholic Acid treated patients relative to placebo achieving at least one stage of liver fibrosis improvement with no worsening of NASH, or The proportion of Obeticholic Acid treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis.
To evaluate the effect of Obeticholic Acid compared to placebo on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint)
Primary endpoint events include: Death (all cause), model of end stage liver disease (MELD) score ≥15, liver transplant, ascites requiring medical intervention, histological progression to cirrhosis, hospitalization (as defined by a stay of ≥24 hours) for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis.

Secondary Outcome Measures

To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either No worsening of fibrosis AND no worsening of NASH Improvement in each histological feature of NASH by at least 1 point Improvement of fibrosis by at least 2 stages Improvement in NAS by at least 2 points with no worsening of fibrosis Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject Resolution of fibrosis Histological progression to cirrhosis
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
Improvement in fibrosis by at least 1 stage with no worsening of NASH NASH resolution with no worsening of fibrosis Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either No worsening of fibrosis AND no worsening of NASH Improvement in each histological feature of NASH by at least 1 point Improvement of fibrosis by at least 2 stages Improvement in NAS by at least 2 points with no worsening of fibrosis Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject Resolution of fibrosis
To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function

Full Information

First Posted
September 1, 2015
Last Updated
October 13, 2023
Sponsor
Intercept Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02548351
Brief Title
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
Acronym
REGENERATE
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. The FDA indicated the review was complete and determined it cannot be approved. Sponsor decided to terminate 747-303 before the planned completion date.
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercept Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis (NASH)
Keywords
Non Alcoholic Steatohepatitis, fatty liver disease, NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg Obeticholic Acid
Arm Type
Experimental
Arm Description
10 mg Obeticholic Acid daily for the remainder of the study
Arm Title
25 mg Obeticholic Acid
Arm Type
Experimental
Arm Description
25 mg Obeticholic Acid daily for the remainder of the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet daily for the remainder of the study
Intervention Type
Drug
Intervention Name(s)
Obeticholic Acid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with stage 2 or 3 fibrosis by assessing the following primary endpoints
Description
Primary endpoints include: The proportion of Obeticholic Acid treated patients relative to placebo achieving at least one stage of liver fibrosis improvement with no worsening of NASH, or The proportion of Obeticholic Acid treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis.
Time Frame
Measurements at Baseline and 18 months
Title
To evaluate the effect of Obeticholic Acid compared to placebo on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint)
Description
Primary endpoint events include: Death (all cause), model of end stage liver disease (MELD) score ≥15, liver transplant, ascites requiring medical intervention, histological progression to cirrhosis, hospitalization (as defined by a stay of ≥24 hours) for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis.
Time Frame
Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 7 years
Secondary Outcome Measure Information:
Title
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
Description
Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either No worsening of fibrosis AND no worsening of NASH Improvement in each histological feature of NASH by at least 1 point Improvement of fibrosis by at least 2 stages Improvement in NAS by at least 2 points with no worsening of fibrosis Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject Resolution of fibrosis Histological progression to cirrhosis
Time Frame
18 month Interim Analysis
Title
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
Description
Improvement in fibrosis by at least 1 stage with no worsening of NASH NASH resolution with no worsening of fibrosis Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either No worsening of fibrosis AND no worsening of NASH Improvement in each histological feature of NASH by at least 1 point Improvement of fibrosis by at least 2 stages Improvement in NAS by at least 2 points with no worsening of fibrosis Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject Resolution of fibrosis
Time Frame
End of Study, estimated to be 7 years
Title
To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function
Time Frame
18 months and End of Study, estimated to be 7 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34793868
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.
Results Reference
derived
PubMed Identifier
34274514
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.
Results Reference
derived
PubMed Identifier
31813633
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. Erratum In: Lancet. 2020 Aug 1;396(10247):312. Lancet. 2021 Jun 19;397(10292):2336.
Results Reference
derived
PubMed Identifier
31260793
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.
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Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

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