Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT02704403
- Lead Sponsor
- Genfit
- Brief Summary
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2157
-
Males or females aged from 18 to 75 years inclusive at first screening visit.
-
Must provide signed written informed consent and agree to comply with the study protocol.
-
Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:
- Cessation of menses for at least 12 months due to ovarian failure,
- Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
- If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
- Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
- Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
-
Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
-
NAS score ≥4.
-
Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
-
Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
-
For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
- No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
- No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).
Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.
- Known heart failure (Grade I to IV of New York Heart Association classification).
- History of efficient bariatric surgery within 5 years prior to screening.
- Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy
- Type 1 diabetes participants .
- Participants with decompensated diabetes (HbA1c>9%).
- Participants with a history of clinically significant acute cardiac event within 6 months prior to screening
- Weight loss of more than 5% within 6 months prior to randomization
- Compensated and decompensated cirrhosis
- Current or recent history (<5 years) of significant alcohol consumption
- Pregnant or lactating females or females planning to become pregnant during the study period.
- Other well documented causes of chronic liver disease according to standard diagnostic procedures
- Participants with previous exposure to Elafibranor
- Prohibited concomitant medication
- Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
- Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- Participants with biological criteria exclusion as per effective protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water 120 mg Elafibranor Elafibranor Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
- Primary Outcome Measures
Name Time Method Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis Measurement at 72 weeks To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Measurements after 72 weeks of treatment and up to study termination High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage Measurements at 72 weeks To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Measurements after 72 weeks of treatment and up to study termination Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Measurements after 72 weeks of treatment and up to study termination Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants Measurements after 72 weeks of treatment and up to study termination Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Measurements after 72 weeks of treatment and up to study termination Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Measurements after 72 weeks of treatment and up to study termination Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
Trial Locations
- Locations (319)
Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Integrity Clinical Research LLC
🇺🇸Doral, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of California, San Diego Airway Research and Clinical Trials Center
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
VA San Diego HealthCare System
🇺🇸San Diego, California, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
University of Miami - Miller School of Medicine
🇺🇸Miami, Florida, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Ohio Gastroenterology & Liver Institute
🇺🇸Cincinnati, Ohio, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
The Texas Liver Institute, Inc.
🇺🇸San Antonio, Texas, United States
Sutter West Bay Hospitals dba California Pacific Medical Center
🇺🇸San Francisco, California, United States
Dignity Health St. Joseph's Hospital
🇺🇸Phoenix, Arizona, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Quality Medical Research, PLLC
🇺🇸Nashville, Tennessee, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
The Institute for Liver Health
🇺🇸Glendale, Arizona, United States
Instituto de Investigaciones Clinicas San Nicolas SRL
🇦🇷San Nicolas, Buenos Aires, Argentina
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Institute for Liver Health
🇺🇸Tucson, Arizona, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Fundación Sanatorio Güemes
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Argentina
Hospital Provincial del Centenario
🇦🇷Rosario, Argentina
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
LAIR Centre
🇨🇦Vancouver, British Columbia, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hôpital Erasme
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Georgetown University Hospitals
🇺🇸Washington, District of Columbia, United States
Caparra Internal Medicine Research Center
🇵🇷Rio Grande, Puerto Rico
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Alta Salud
🇨🇱Los Ángeles, Chile
Centro Hospitalar de São João
🇵🇹Porto, Portugal
Rutgers, New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
Hospital Alemán
🇦🇷Buenos Aires, Argentina
Centro De Hepatologia Ciudad de La Plata
🇦🇷La Plata, Argentina
Instituto Medico Alas
🇦🇷Salta, Argentina
Universitair Ziekenhuis Brussel
🇧🇪Bruxelles, Belgium
Centre Hospitalier de Wallonie Picardie (CHWAPI)
🇧🇪Tournai, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Hospital Clínico UC
🇨🇱Santiago, Chile
Hospital Clínico Universidad de Chile
🇨🇱Santiago, Chile
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Colombia
Fundacion Hospitalaria San Vicente de Paul
🇨🇴Medellín, Colombia
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
The Montreal Chest Institute
🇨🇦Montréal, Quebec, Canada
Clínica Reñaca
🇨🇱Vina Del Mar, Chile
Hospital Universitario San Vicente de Paul Fundación
🇨🇴Medellin, Colombia
Centro Medico Imbanaco
🇨🇴Cali, Colombia
Centro Hospita de Tras-os-Montes e Alto Douro, EPE
🇵🇹Vila Real, Portugal
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
🇹🇷Istanbul, Turkey
CHU de Nice- Hôpital de l'Archet II
🇫🇷Nice, France
CHU Nancy - Hôpital Brabois
🇫🇷Vandoeuvre Les Nancy, France
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Northwestern Memorial Hospital - Arkes Family Pavilion
🇺🇸Chicago, Illinois, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
South Florida Center of Gastroenterology, PA
🇺🇸Wellington, Florida, United States
Atlanta Medical Center, Inc.
🇺🇸Atlanta, Georgia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Summit Clinical Research
🇺🇸Athens, Georgia, United States
University at Buffalo, Clinical and Translational Research Center
🇺🇸Buffalo, New York, United States
Hofstra Northwell School of Medicine
🇺🇸Manhasset, New York, United States
Gastrointestinal Associates & Endoscopy Center
🇺🇸Flowood, Mississippi, United States
Concorde Medical Group
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Duke Gastroenterology
🇺🇸Durham, North Carolina, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Premier Medical Group
🇺🇸Poughkeepsie, New York, United States
Associates in Gastroenterology, PLC
🇺🇸Hermitage, Tennessee, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Baylor All Saints Medical Center - Baylor Research Institute
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Centex Studies Inc.
🇺🇸Houston, Texas, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Brooke Army Medical Center
🇺🇸Houston, Texas, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Hospital Británico de Buenos Aires
🇦🇷Buenos Aires, Argentina
St. Vincent's Hospital Melbourne
🇦🇺Fitzroy, Australia
Nepean Hospital
🇦🇺Kingswood, Australia
Axismed S.R.L
🇦🇷Caba, Buenos Aires, Argentina
Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
🇦🇷Buenos Aires, Argentina
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
Sanatorio Güemes
🇦🇷Caba, Buenos Aires, Argentina
University of Calgary, Cumming School of Medicine
🇨🇦Calgary, AB, Canada
Mc Gill University Health Centre (MUHC)
🇨🇦Montreal, Canada
Monash Medical Centre Clayton
🇦🇺Clayton, Australia
Flinders Medical Centre
🇦🇺Bedford Park, Australia
Box Hill Hospital
🇦🇺Box Hill, Australia
CCBR Clinical Research
🇦🇷Buenos Aires, Argentina
Dim Clinica Privada
🇦🇷Ramos Mejía, Argentina
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
🇨🇦Halifax, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Concord Repatriation General Hospital
🇦🇺Concord, Australia
The St George Hospital
🇦🇺Kogarah, Australia
Monteregie Centre de Recherche
🇨🇦Greenfield Park, Quebec, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Westmead Hospital
🇦🇺Westmead, Australia
Hospital de La Serena
🇨🇱La Serena, Chile
Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
🇨🇱Santiago, Chile
Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
🇨🇴Bogotá, Bogota D.C, Colombia
Fundación Cardio Infantil - Instituto de Cardiología
🇨🇴Bogotá, Colombia
Fundación Valle del Lili
🇨🇴Cali, Colombia
Research Site S.R.O.
🇨🇿Plzen, Czechia
Fakultní Nemocnice Brno
🇨🇿Brno, Czechia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Hospital Maria Auxiliadora
🇲🇽Guadalajara, Mexico
Médica Sur
🇲🇽Mexico City, Mexico
Accelerium S de RL de C.V.
🇲🇽Monterrey, Mexico
Vrije Universiteit Medical Center
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
CHU Amiens Picardie
🇫🇷Amiens, France
CHU Angers
🇫🇷Angers, France
Hôpital Antoine-Béclère
🇫🇷Clamart, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
Hôpital Saint-Antoine
🇫🇷Paris, France
KlinMed s.r.o.
🇨🇿Praha 2, Czechia
Hôpital Cochin
🇫🇷Paris, France
Policlinico Tor Vergata
🇮🇹Roma, Italy
Aarhus University Hospital
🇩🇰Aarhus, Denmark
CHRU Montpellier- Hôpital Saint Eloi
🇫🇷Montpellier, France
Hôpital Beaujon
🇫🇷Clichy, France
CHU Limoges - Hôpital Dupuytren
🇫🇷Limoges, France
Research Site, s.r.o
🇨🇿Plzen, Czechia
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
CHU de Nantes - Hôpital Laennec
🇫🇷Nantes, France
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
CHU Toulouse - Hôpital Purpan
🇫🇷Toulouse, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Centro de Investigación Clínica del Pacífico, S.A de C.V.
🇲🇽Acapulco, Mexico
Radboud UMC
🇳🇱Nijmegen, Netherlands
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Liver Center
🇩🇪Berlin, Germany
Maastricht UMC+
🇳🇱Maastricht, Netherlands
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
🇵🇹Lisboa, Portugal
Klinical Investigations Group, LLC
🇵🇷San Juan, Puerto Rico
Fundación de Investigación
🇵🇷San Juan, Puerto Rico
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Military medical academy n. a. S.M. Kirov
🇷🇺Saint Petersburg, Russian Federation
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
🇮🇹Napoli, Italy
Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
🇮🇹San Giovanni Rotondo, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
🇮🇹Torino, Italy
Universitätsklinikum RWTH Aachen
🇩🇪Aachen, Germany
Hôpital Haut-Lévêque
🇫🇷Pessac, France
FSBRI "Federal Research Center of nutrition and biotechnology
🇷🇺Moscow, Russian Federation
I. M. Sechenov - First Moscow State Medical University
🇷🇺Moscow, Russian Federation
Hospital Angeles Clinica Londres
🇲🇽Mexico, DIF, Mexico
Consultorio Medico
🇲🇽Mexico City, Mexico
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
🇵🇹Lisboa, Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
🇵🇹Porto, Portugal
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
🇷🇴Bucharest, Romania
SC Cabinet Particular Policlinic Algomed SRL
🇷🇴Timisoara, Romania
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
🇷🇴Timisoara, Romania
City Clinical Hospital No. 31
🇷🇺St. Petersburg, Russian Federation
Tiervlei Trial Centre
🇿🇦Cape Town, South Africa
Plymouth Hospitals NHS Trust - Derriford Hospital
🇬🇧Plymouth, United Kingdom
Mediclinic Constantiaberg
🇿🇦Cape Town, South Africa
St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
🇷🇺Saint Petersburg, Russian Federation
Phoenix Pharma (Pty) Ltd
🇿🇦Port Elizabeth, South Africa
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
INSELSPITAL, University Hospital Bern
🇨🇭Bern, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Switzerland
Kantonsspital St. Gallen
🇨🇭Saint Gallen, Switzerland
UniversitätsSpital Zürich
🇨🇭Zurich, Switzerland
Ankara Üniversitesi Tıp Fakültesi
🇹🇷Ankara, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi
🇹🇷Çapa, Turkey
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Frimley Park Hospital NHS Foundation Trust
🇬🇧Frimley, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
🇬🇧Hull, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Bart Health NHS Trust- Royal London Hospital
🇬🇧London, United Kingdom
Bezmiâlem Vakıf Üniversitesi
🇹🇷Fatih, Turkey
Ege Üniversitesi
🇹🇷Izmir, Turkey
University Hospitals Birmingham NHS foundation Trust
🇬🇧Birmingham, United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
🇬🇧London, United Kingdom
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
🇹🇷Pendik, Turkey
Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Universitätsklinikum Köln
🇩🇪Köln, Germany
Gastroenterologie am Bayerischen Platz/ Gastro-Studien
🇩🇪Berlin, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
🇩🇪Hamburg, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Frankfurt - Goethe Universität
🇩🇪Frankfurt, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Saint Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Complexo Hospitalario Universitario de Pontevedra
🇪🇸Pontevedra, Spain
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
🇪🇸Sevilla, Spain
The Alfred Hospital
🇦🇺Melbourne, Australia
Sir Charles Gairdner Hospital (SCGH)
🇦🇺Nedlands, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Gastroenterology Associates of Hazard
🇺🇸Hazard, Kentucky, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian Hospital - Columbia University Medical Center
🇺🇸New York, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Diabetes & Endocrinology Consultants
🇺🇸Morehead City, North Carolina, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
🇺🇸Huntersville, North Carolina, United States
Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Drexel University, College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Trial Management Associates
🇺🇸Wilmington, North Carolina, United States
Temple University Health System
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Montefiore
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Liver Center of Texas
🇺🇸Dallas, Texas, United States
Liver Associates of Texas, P.A.
🇺🇸Houston, Texas, United States
Gulf Coast Research Group LLC
🇺🇸Houston, Texas, United States
Centex Studies Inc
🇺🇸McAllen, Texas, United States
Gastroenterology Consultants of San Antonio
🇺🇸Live Oak, Texas, United States
Texas Digestive Consultants (TDDC)
🇺🇸Southlake, Texas, United States
Pinnacle Clinical Research, PLLC
🇺🇸San Antonio, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Victoria Gastroenterology
🇺🇸Victoria, Texas, United States
Bon Secours Liver Institute of Virginia - Richmond
🇺🇸Richmond, Virginia, United States
Hunter Holmes McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Bon Secours Liver Institute of Virginia - Newport News
🇺🇸Newport News, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Kaiser Permanente Springfield Medical Center
🇺🇸Springfield, Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Henry Ford Health System, Division of Gastroenterology & Hepatology
🇺🇸Detroit, Michigan, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
The University of Arizona College of Medicine Liver Research Institute
🇺🇸Tucson, Arizona, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
University of Cincinnati Physicians Company , LLC
🇺🇸Cincinnati, Ohio, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Inova Fairfax Medical Campus - Center for Liver Disease
🇺🇸Falls Church, Virginia, United States
Mayo Clinic Hospital
🇺🇸Jacksonville, Florida, United States
GW Research, Inc.
🇺🇸Chula Vista, California, United States
Fresno Clinical Research Center
🇺🇸Fresno, California, United States
Liver Wellness Center
🇺🇸Little Rock, Arkansas, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Scripps Clinic Torrey Pines
🇺🇸La Jolla, California, United States
University of California, San Francisco, Fresno Community Regional Medical Center
🇺🇸Fresno, California, United States
University of California - San Diego
🇺🇸La Jolla, California, United States
Loma Linda University Medical Center - Transplantation Insitute
🇺🇸Loma Linda, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Gastrointestinal Biosciences Clinical Trials LLC
🇺🇸Los Angeles, California, United States
Alliance Clinical Research
🇺🇸Poway, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
University of California, San Francisco, Medical Center at Parnassus
🇺🇸San Francisco, California, United States
Ventura Clinical Trials
🇺🇸Ventura, California, United States
Excel Medical Clinical Trials LLC
🇺🇸Boca Raton, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Florida Digestive Health Specialists, LLP
🇺🇸Lakewood Ranch, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Atlantic Gastroenterology Associates, LLC
🇺🇸Lakewood Ranch, Florida, United States
University of Miami - Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Kaiser Permanente Shady Grove Medical Center
🇺🇸Rockville, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Rutgers, Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Southwest Gastroenterology Associates
🇺🇸Albuquerque, New Mexico, United States
Austin Hospital
🇦🇺Heidelberg, Australia
University of Manitoba
🇨🇦Winnipeg, MB, Canada
Hôpital Henri Mondor
🇫🇷Créteil, France
Yale University School of Medicine, Section of Digestive Diseases
🇺🇸New Haven, Connecticut, United States
University of Louisville Medical / Dental Complex
🇺🇸Louisville, Kentucky, United States
St. Luke's Liver Transplant & Specialist
🇺🇸Kansas City, Missouri, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
UNC Health Care System
🇺🇸Chapel Hill, North Carolina, United States
Ralph H. Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
M. F. Vladimirsky - Clinical Research Institution of Moscow Region
🇷🇺Moscow, Russian Federation
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
🇬🇧London, United Kingdom
St George's University Hospitals NHS Foundation Trust - St George's Hospital
🇬🇧London, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States