Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Interventions
- Drug: Obeticholic AcidDrug: Placebo
- Registration Number
- NCT02548351
- Lead Sponsor
- Intercept Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2477
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg Obeticholic Acid Obeticholic Acid 10 mg Obeticholic Acid daily for the remainder of the study Placebo Placebo One tablet daily for the remainder of the study 25 mg Obeticholic Acid Obeticholic Acid 25 mg Obeticholic Acid daily for the remainder of the study
- Primary Outcome Measures
Name Time Method Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event Up to 7 years All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology.
- Secondary Outcome Measures
Name Time Method Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies Up to 7 years Fibrosis stage was evaluated by NASH Clinical Research Network (CRN) Fibrosis Staging System as follows: Stage 0: No fibrosis, Stage 1: Perisinusoidal/periportal fibrosis, Stage 1A: Mild, zone 3, perisinusoidal fibrosis, Stage 1B: Moderate, zone 3, perisinusoidal fibrosis, Stage 1C: Portal/periportal fibrosis, Stage 2: Perisinusoidal and portal/periportal fibrosis, Stage 3: Bridging fibrosis and Stage 4: Cirrhosis. No worsening of NASH was defined as no worsening of hepatocellular ballooning, no worsening of lobular inflammation, and no worsening of steatosis. Responders are defined as participants who did not discontinue treatment due to Adverse event (AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct the confidence intervals.
Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method Up to 7 years Fibrosis stage was evaluated by NASH Clinical Research Network(CRN) Fibrosis Staging System as follows: Stage 0:No fibrosis, Stage 1:Perisinusoidal/periportal fibrosis, Stage 1A:Mild, zone 3, perisinusoidal fibrosis, Stage 1B:Moderate, zone3, perisinusoidal fibrosis, Stage 1C:Portal/periportal fibrosis, Stage 2:Perisinusoidal and portal/periportal fibrosis, Stage 3:Bridging fibrosis and Stage 4:Cirrhosis. Resolution of NASH (Nonalcoholic Steatohepatitis) is defined as absence of fatty liver disease, or presence of simple or isolated steatosis without steatohepatitis, with a NAS(NAFLD Activity Score) of 0 for ballooning and 0 to 1 for inflammation. NAS ranges from 0-12; 0: no features of fatty liver disease and 12: highest degree of fatty liver disease. Higher signify worse symptoms. Responders are who did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct confidence intervals.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to 7 years An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that either newly appeared, increased in frequency, or worsened in severity following treatment up to 30 days from last dose of permanent investigational product discontinuation. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Trial Locations
- Locations (343)
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
CHRU Hôpital Claude Huriez
🇫🇷Lille, France
Institute for Liver Health DBA Arizona Liver Health
🇺🇸Chandler, Arizona, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Einstein Healthcare Network
🇺🇸Philadelphia, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Austin Hospital
🇦🇺Heidelberg, Australia
Nepean Hospital
🇦🇺Kingswood, Australia
The Alfred Hospital, Department of Gastroenterology
🇦🇺Melbourne, Australia
GI Research
🇨🇦Edmonton, Canada
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Westmead Hospital
🇦🇺Westmead, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Australia
Universitätsklinik für Innere Medizin I Innsbruck
🇦🇹Innsbruck, Austria
Royal Brisbane and Women's Hospital
🇦🇺Herston, Australia
John Buhler Research Centre
🇨🇦Winnipeg, Canada
Copenhagen University Hospital Hvidovre
🇩🇰Hvidovre, Denmark
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hopital Paul Brousse
🇫🇷Villejuif, France
CHU Toulouse - Hopital de Purpan
🇫🇷Toulouse, France
Carmel Medical Center
🇮🇱Haifa, Israel
Service d'Hepato-Gastroenterologie CHR Orleans - La Source
🇫🇷Orléans, France
Hôpital Cochin
🇫🇷Paris, France
Policlinico University Campus Biomedico
🇮🇹Rome, Italy
CHU de Rouen
🇫🇷Rouen, France
Hospital Saint Antoine Department of Hepatology
🇫🇷Paris, France
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Fondazione IRCCS Ca Granda Ospedale
🇮🇹Milano, Italy
AOU di Modena Ospedale Civile
🇮🇹Modena, Italy
Hospital Clinic(o) de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Centrum Badan Klinicznych Piotr Napora
🇵🇱Wroclaw, Poland
Hospital del Mar Gastroenterology Department
🇪🇸Barcelona, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Ulsba, Epe
🇵🇹Beja, Portugal
Ave Ponce De Leon #715
🇵🇷San Juan, Puerto Rico
UVCM Hepatologie
🇨🇭Bern, Switzerland
John Radcliffe Hospital
🇬🇧Headington, Oxford, United Kingdom
Consorcio Hospital General Universitario
🇪🇸Valencia, Spain
Hospital General y Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Fundación Alcorcon
🇪🇸Alcorcón, Spain
Hospital Universitario Donostia
🇪🇸San Sebastian, Spain
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Universitetsjukhuset Linkoping
🇸🇪Linkoping, Sweden
Institute of Biomedical Research
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Complejo Asistencial Universitario de Leon
🇪🇸Leon, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Epatocentro Ticino
🇨🇭Lugano, Switzerland
Gastroenterology Department Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Hospital (Universitario) Marqués de Valdecilla
🇪🇸Santander, Spain
University Hospitals Coventry & Warwickshire
🇬🇧Coventry, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Institute for Liver and Digestive Health
🇬🇧London, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Bruce W. Carter Miami VA Medical Center
🇺🇸Miami, Florida, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Indianapolis Gastroenterology & Hepatology
🇺🇸Indianapolis, Indiana, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Arizona Liver Health - Glendale
🇺🇸Glendale, Arizona, United States
UCSF Fresno, Clinical Research Center
🇺🇸Fresno, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Janus Clinical Research, Inc.
🇺🇸Miami, Florida, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Huron Gastroenterology Associates/Center for Digestive Care
🇺🇸Ypsilanti, Michigan, United States
Southern Therapy and Advanced Research, LLC
🇺🇸Jackson, Mississippi, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Saint Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Concorde Medical Group PLLC
🇺🇸New York, New York, United States
New York University (NYU) Langone Medical Center
🇺🇸New York, New York, United States
Center for Liver Disease
🇺🇸Charlotte, North Carolina, United States
East Tennesse Research Institute
🇺🇸Johnson City, Tennessee, United States
The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition
🇺🇸Houston, Texas, United States
Royal Adelaide Hospital Gastroenterology and Hepatology Dept.
🇦🇺Adelaide, Australia
Flinders Medical Centre
🇦🇺Bedford Park, Australia
AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
Monash Health - Monash Medical Centre
🇦🇺Clayton, Australia
Gallipoli Medical Research Foundation
🇦🇺Greenslopes, Australia
CHU de Nancy - Hôpital de Brabois adultes
🇫🇷Vandoeuvre-Lès-Nancy, France
St. Josef-Hospital, Ruhr University Bochum
🇩🇪Bochum, Germany
Universitätsklinikum Hamburg- Eppendorf
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Hepato-Gastroenterology Center Kiel
🇩🇪Kiel, Germany
Egyesitett Szent Istvan és Szent Laszlo
🇭🇺Budapest, Hungary
Kenezy Gyula Korhaz es Rendelointezet
🇭🇺Debrecen, Hungary
Soroka Medical Center Division of Internal Medicine
🇮🇱Be'er Sheva, Israel
Policlinico Paolo Giaccone di Palermo
🇮🇹Palermo, Italy
Fundacion de Investigacion
🇵🇷San Juan, Puerto Rico
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital Universitario La Fe.
🇪🇸Valencia, Spain
Hospital of St. Gallen
🇨🇭St.Gallen, Switzerland
Cambridge University Hospital
🇬🇧Cambridge, United Kingdom
Glasgow Royal Infirmary, NHS Greater
🇬🇧Glasgow, United Kingdom
Nottingham Digestive Diseases and Biomedical Research Unit
🇬🇧Nottingham, United Kingdom
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
GW Research Inc.
🇺🇸Chula Vista, California, United States
Precision Research Institute
🇺🇸Chula Vista, California, United States
Citrus Valley Gastroenterology
🇺🇸Covina, California, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Fresno Clinical Research Center
🇺🇸Fresno, California, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
National Research Institute, Wilshire
🇺🇸Los Angeles, California, United States
Gastrointestinal Biosciences
🇺🇸Los Angeles, California, United States
Veteran Affairs Great Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
The Emory Clinic (TEC)
🇺🇸Atlanta, Georgia, United States
Northwestern University, Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
The Medical Center of Bowling Green
🇺🇸Bowling Green, Kentucky, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
University at Buffalo, Clinical and Translational Research Center
🇺🇸Buffalo, New York, United States
Saint Louis University Gastroenterology & Hepatology
🇺🇸Saint Louis, Missouri, United States
Washington University School of Medicine - Gastroenterology
🇺🇸Saint Louis, Missouri, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Charlotte Gastroenterology & Hepatology
🇺🇸Charlotte, North Carolina, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Carolinas Center for Liver Disease/Carolinas HeatlhCare System
🇺🇸Huntersville, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Doylestown Health Gastroenterology
🇺🇸Doylestown, Pennsylvania, United States
Hillmont GI, pc
🇺🇸Flourtown, Pennsylvania, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Hillmont G.I. - Lansdale Office
🇺🇸Lansdale, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Liver Center of Texas
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Digestive Disease Consultants
🇺🇸Fort Worth, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
MedResearch, Inc.
🇺🇸El Paso, Texas, United States
Baylor Scott & White All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Liver Associates of Texas, P.A.
🇺🇸Houston, Texas, United States
Centex Studies, Inc.
🇺🇸McAllen, Texas, United States
Texas Digestive Disease Consultants - San Marcos
🇺🇸San Marcos, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Virginia Mason - Seattle Medical Center
🇺🇸Seattle, Washington, United States
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
eStudy Site
🇺🇸San Diego, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
California Pacific Medical Center (CPMC)
🇺🇸San Francisco, California, United States
UCSF/ San Francisco General Hospital
🇺🇸San Francisco, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville Gastrointestinal Specialists
🇺🇸Nashville, Tennessee, United States
Quality Medical Research, PLLC
🇺🇸Nashville, Tennessee, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Gastroenterology Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Minnesota Gastroenterology
🇺🇸Minneapolis, Minnesota, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Western States Clinical Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling
🇩🇰Aarhus, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
ProLive Medical Research
🇺🇸Miami, Florida, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Meridien Research
🇺🇸Maitland, Florida, United States
Sunrise Medical Research, Inc.
🇺🇸Lauderdale Lakes, Florida, United States
Amici GI - LLC
🇺🇸Martinsville, New Jersey, United States
Liver Wellness Center
🇺🇸Little Rock, Arkansas, United States
Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Florida Digestive Health Specialist Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
UF Health Jacksonville-Gastroenterology Emerson
🇺🇸Jacksonville, Florida, United States
Ordensklinikum Linz GmbH
🇦🇹Linz, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
UZ Leuven Campus Gathuisberg Hepatology Department
🇧🇪Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan Brugge Oostende
🇧🇪Brugge, Belgium
UCL Saint-Luc - Hepatology Department
🇧🇪Brussels, Belgium
UZ Gent Gastroenterology Department
🇧🇪Ghent, Belgium
Turku University Hospital
🇫🇮Turku, Finland
CHU Amiens Picardie
🇫🇷Amiens, France
Centre hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Hôpital de l'Archet II-CHU Nice
🇫🇷Nice, France
Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN
🇫🇷Pessac, France
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Hôpital de la Pitié Salpétrère
🇫🇷Paris, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research
🇺🇸Wyoming, Michigan, United States
Prisma Health- Upstate Gastroenterology and Liver Center
🇺🇸Greenville, South Carolina, United States
Rapid City Medical Center
🇺🇸Rapid City, South Dakota, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
GIRI - GI Research Institute
🇨🇦Vancouver, Canada
Katholische Kliniken Ruhrhalbinsel GmbH
🇩🇪Essen, Germany
Rambam Medical Center Center for Liver diseases
🇮🇱Haifa, Israel
Shaarei Zedek Medical Center
🇮🇱Jerusalem, Israel
Hadassah Ein Kerem MC
🇮🇱Jerusalem, Israel
University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC
🇮🇹Bologna, Italy
Ospedale san Giuseppe - Multimedica
🇮🇹Milan, Italy
Rutgers University New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1
🇩🇪Erlangen, Bavaria, Germany
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Associates in Gastroenterology, PLC
🇺🇸Hermitage, Tennessee, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
The University of Vermont Medical Center - Smith 2
🇺🇸Burlington, Vermont, United States
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
WR-Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego
🇵🇱Lodz, Poland
London Health Sciences Centre University Hospital
🇨🇦London, Ontario, Canada
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt, Austria
ULB Hȏpital Erasme - Gastroenterology
🇧🇪Brussels, Brabant, Belgium
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Canada
Toronto Center for Liver Disease
🇨🇦Toronto, Canada
LAIR Centre
🇨🇦Vancouver, Canada
PerCuro Clinical Research Ltd.
🇨🇦Victoria, Canada
Helsinki University Hospital
🇫🇮Helsinki, Finland
CHU Angers-Service d'Hepato-Gastroenterologie
🇫🇷Angers, France
Hôpital Henri Mondor - Service d'hépatologie
🇫🇷Creteil, France
Gastroenterologische Gemeinschaftspraxis
🇩🇪Herne, Germany
Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie
🇩🇪Munich, Germany
Universita di Bologna - DIMEC
🇮🇹Bologna, Italy
Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie
🇩🇪Leipzig, Saxony, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz
🇭🇺Budapest, Hungary
Ziekenhuis Oost-Limburg (ZOL)
🇧🇪Genk, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
University of Calgary Liver Unit
🇨🇦Calgary, Canada
University of Alberta
🇨🇦Edmonton, Canada
The Research Institute of the McGill University Health Centre
🇨🇦Montreal, Canada
Toronto Liver Centre
🇨🇦Toronto, Canada
Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, Canada
CHU Beaujon-Service d'Hépatologie
🇫🇷Clichy, France
CHU Grenoble
🇫🇷Grenoble, France
University Hospital Essen
🇩🇪Essen, Germany
Holy Family Medical Center
🇮🇱Nazareth, Israel
Rabin Medical Center, Liver Institute
🇮🇱Petach Tikva, Israel
Sourasky Tel-Aviv Medical Center
🇮🇱Tel Aviv, Israel
A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria
🇵🇹Lisboa, Portugal
Klinical Investigations Group, LLC
🇵🇷San Juan, Puerto Rico
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
🇩🇪Mainz, Rhineland-Palatinate, Germany
Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III
🇩🇪Aachen, Germany
Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie
🇩🇪Heidelberg, Baden-Wurttemberg, Germany
University Hosptial Cologne Clinics for Gastroenterology and Hepatology
🇩🇪Cologne, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Germany
West Galilee Hospital
🇮🇱Nahariya, Israel
Charite Universitätsmedizin Campus Virchow
🇩🇪Berlin, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo
🇮🇹Milano, Italy
NZ Liver Transplant Unit
🇳🇿Grafton, Auckland, New Zealand
Queen Alexandra Hospital
🇬🇧Portsmouth, Hampshire, United Kingdom
Norfolk and Norwich University Hospitals
🇬🇧Norwich, Norfolk, United Kingdom
Royal Surrey NHS Foundation Trust
🇬🇧Guildford, Surrey, United Kingdom
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Fondazione IRCCS Ca Grande Ospedale
🇮🇹Milano, Italy
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdansk, Poland
Centro Hospitalar do Baixo Vouga, E.P.E.
🇵🇹Aveiro, Portugal
Clinical Center Nis
🇷🇸Nis, Serbia
Azienda Ospedaliera Universitaria Policlinico
🇮🇹Napoli, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Middlemore Hospital
🇳🇿Auckland, New Zealand
Hospital da Senhora da Oliveira - Guimarães
🇵🇹Guimarães, Portugal
University Medical Centar Zvezdara
🇷🇸Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Lublin, Poland
Centro Hospitalar Lisboa Ocidental
🇵🇹Lisbon, Portugal
University Clinic of Gastroenterology & Hepatology
🇨🇭Zürich, Switzerland
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Royal London Hospital
🇬🇧London, United Kingdom
University Hospital Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CHI Health Alegent Creighton Clinic Gastroenterology
🇺🇸Omaha, Nebraska, United States
Hospital (Universitario) Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Denver and Hospital
🇺🇸Aurora, Colorado, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Florida Hospital Transplant Institute
🇺🇸Orlando, Florida, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
University of Louisville Medical, Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill, School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
UF Hepatology Research at CTRB
🇺🇸Gainesville, Florida, United States
The Queen's Medical Center - Liver Center
🇺🇸Honolulu, Hawaii, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
AccumetRx Clinical research / UGNM
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Bon Secours St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
McGuire DVAMC GI
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University Clinical Research Services Unit (CRSU)
🇺🇸Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
Arizona Liver Clinic - Tucson
🇺🇸Tucson, Arizona, United States
Methodist Healthcare, University Hospital
🇺🇸Memphis, Tennessee, United States
Guy's and St. Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
Amici Clinical Research
🇺🇸Martinsville, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States