Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02704403
Recruitment Status : Active, not recruiting
First Posted : March 10, 2016
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) With Fibrosis Drug: Elafibranor Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis
Study Start Date : March 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 120 mg Elafibranor
Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
Drug: Elafibranor
Other Name: GFT505

Placebo Comparator: Placebo
Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Drug: Placebo



Primary Outcome Measures :
  1. Proportion of Elafibranor treated patients relative to placebo achieving resolution of NASH without worsening of fibrosis [ Time Frame: Measurement at 72 weeks ]
    To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) subjects with fibrosis by assessing the following endpoint: The proportion of Elafibranor treated patients relative to placebo achieving NASH resolution without worsening of fibrosis.

  2. Composite long-term outcome composed of all-cause mortality, cirrhosis, and liver-related clinical outcomes [ Time Frame: Time to accrue a pre-specified number of adjudicated events, estimated to be 4 years ]
    To evaluate the effect of Elafibranor compared to placebo on composite long-term outcome measured by the number of patients with the onset of any of the adjudicated events, composed of cirrhosis, all-cause mortality, liver-related clinical outcomes.


Secondary Outcome Measures :
  1. Proportion of Elafibranor treated patients relative to placebo achieving improvement of fibrosis [ Time Frame: Measurements at 72 weeks ]
    To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) subjects by assessing the following endpoint: The proportion of Elafibranor treated patients relative to placebo achieving improvement of liver fibrosis of at least one stage.

  2. Proportion of Elafibranor treated patients relative to placebo achieving improvement in histological scores in NASH [ Time Frame: Measurements after 72 weeks of treatment and up to study completion estimated at 4 years of treatment ]
    • Percentage of patients with resolution of NASH without worsening of fibrosis (study completion)
    • Percentage of patients with improvement of fibrosis of at least 1 stage
    • Percentage of patients with at least 1 point improvement in histological scores in NASH

  3. Proportion of Elafibranor treated patients relative to placebo with improvement in cardiometabolic and liver markers [ Time Frame: Measurements at Week 72, and at the end of the Long-term Treatment Period estimated at 4 years ]

    To assess the following endpoints in Elafibranor treated patients relative to placebo, at Week 72 and at the end of the Long-term Treatment Period, estimated at 4 years:

    • cardiovascular events
    • changes in liver enzymes and liver markers
    • changes in non-invasive markers of fibrosis and steatosis
    • changes in lipid parameters
    • variation in body weight
    • changes in insulin resistance and glucose homeostasis markers
    • changes in inflammatory markers
    • changes in quality of life (36-Item Short-Form Health Survey [SF-36]) questionnaire)

  4. Proportion of Elafibranor treated patients relative to placebo having a liver-related death [ Time Frame: Measurements at Week 72, and at the end of the Long-term Treatment Period estimated at 4 years ]

    To assess the following endpoints in Elafibranor treated patients relative to placebo, at Week 72 and at the end of the Long-term Treatment Period, estimated at 4 years:

    o liver-related death




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged from 18 to 75 years inclusive at first screening visit.
  2. Must provide signed written informed consent and agree to comply with the study protocol.
  3. BMI ≤45 kg/m².
  4. Females participating in the study must either not be of childbearing potential (hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of menses for at least 12 months due to ovarian failure) or using efficient double contraception: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device, or other mechanical contraception method + condom or diaphragm or spermicide for the full duration of the study and for 1 month after the end of treatment.
  5. 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).
  6. NAS score ≥4.
  7. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
  8. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
  9. No change in antidiabetic therapy within 6 months prior to liver biopsy

Exclusion Criteria:

  1. Known heart failure (Grade I to IV of New York Heart Association classification).
  2. History of efficient bariatric surgery within 5 years prior to screening.
  3. Uncontrolled hypertension
  4. Type 1 diabetes patients.
  5. Patients with decompensated diabetes (HbA1c>9%).
  6. Patients with a history of clinically significant acute cardiac event within 6 months prior to screening
  7. Weight loss of more than 5% within 6 months prior to randomization
  8. Compensated and decompensated cirrhosis
  9. Current or recent history (<5 years) of significant alcohol consumption
  10. Pregnant or lactating females or females planning to become pregnant during the study period.
  11. Other well documented causes of chronic liver disease according to standard diagnostic procedures
  12. Patients with previous exposure to Elafibranor
  13. Prohibited concomitant medication
  14. Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
  15. Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
  16. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704403


Locations
Hide Hide 326 study locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
United States, Arizona
The Institute for Liver Health
Chandler, Arizona, United States, 85224
The Institute for Liver Health
Glendale, Arizona, United States, 85306
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Dignity Health St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Institute for Liver Health
Tucson, Arizona, United States, 85711
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
The University of Arizona College of Medicine Liver Research Institute
Tucson, Arizona, United States, 85724-0001
United States, Arkansas
Liver Wellness Center
Little Rock, Arkansas, United States, 72205
United States, California
GW Research, Inc.
Chula Vista, California, United States, 91910
Southern California Research Center
Coronado, California, United States, 92118
University of California, San Francisco, Fresno Community Regional Medical Center
Fresno, California, United States, 93701-2302
Fresno Clinical Research Center
Fresno, California, United States, 93720
University of California, San Francisco, Fresno Community Regional Medical Center
Fresno, California, United States, 93721
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
University of California - San Diego
La Jolla, California, United States, 92037
Loma Linda University Medical Center - Transplantation Insitute
Loma Linda, California, United States, 92354
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Keck Hospital of USC
Los Angeles, California, United States, 90033
Ruane Clinical Research Group Inc.
Los Angeles, California, United States, 90036
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Gastrointestinal Biosciences Clinical Trials LLC
Los Angeles, California, United States, 90067
Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
Los Angeles, California, United States, 90073
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Alliance Clinical Research
Oceanside, California, United States, 92056
National Research Institute
Panorama City, California, United States, 91402
Alliance Clinical Research
Poway, California, United States, 92064
University of California, Davis Medical Center
Sacramento, California, United States, 95817
University of California, San Diego Airway Research and Clinical Trials Center
San Diego, California, United States, 92103
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
VA San Diego HealthCare System
San Diego, California, United States, 92161
Quest Clinical Research
San Francisco, California, United States, 94115
Sutter West Bay Hospitals dba California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States, 94143
Ventura Clinical Trials
Ventura, California, United States, 93003
United States, Colorado
South Denver Gastroenterology
Englewood, Colorado, United States, 80113
United States, Connecticut
Yale University School of Medicine, Section of Digestive Diseases
New Haven, Connecticut, United States, 65200
United States, District of Columbia
Georgetown University Hospitals
Washington, District of Columbia, United States, 20007
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
Integrity Clinical Research LLC
Doral, Florida, United States, 33166
University of Florida
Gainesville, Florida, United States, 32610
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Mayo Clinic Hospital
Jacksonville, Florida, United States, 32224
Florida Digestive Health Specialists, LLP
Lakewood Ranch, Florida, United States, 34211-4930
Atlantic Gastroenterology Associates, LLC
Lakewood Ranch, Florida, United States, 34211
Miami VA Healthcare System
Miami, Florida, United States, 33125-1624
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
South Florida Center of Gastroenterology, PA
Wellington, Florida, United States, 33414
Florida Medical Clinic, PA
Zephyrhills, Florida, United States, 33542
United States, Georgia
Summit Clinical Research
Athens, Georgia, United States, 30607
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Atlanta Medical Center, Inc.
Atlanta, Georgia, United States, 30312
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060-8949
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern Memorial Hospital - Arkes Family Pavilion
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60637
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University of Chicago
Chicago, Illinois, United States, 60637
Loyola University Chicago
Maywood, Illinois, United States, 60153
United States, Kentucky
Gastroenterology Associates of Hazard
Hazard, Kentucky, United States, 41701
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
University of Louisville Medical / Dental Complex
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Kaiser Permanente Shady Grove Medical Center
Rockville, Maryland, United States, 20850
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 06155
United States, Michigan
Henry Ford Health System, Division of Gastroenterology & Hepatology
Detroit, Michigan, United States, 48202
United States, Mississippi
Gastrointestinal Associates & Endoscopy Center
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Liver Transplant & Specialist
Kansas City, Missouri, United States, 64111
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Saint Louis University School of Medicine
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 89030
Rutgers, New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New Mexico
Southwest Gastroenterology Associates
Albuquerque, New Mexico, United States, 87109
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
University at Buffalo, Clinical and Translational Research Center
Buffalo, New York, United States, 14203
Hofstra Northwell School of Medicine
Manhasset, New York, United States, 11030
Concorde Medical Group
New York, New York, United States, 10016
New York University Langone Medical Center
New York, New York, United States, 10016
Weill Medical College of Cornell University
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
New York-Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States, 10032
Beth Israel Medical Center
New York, New York, United States, 45267
Premier Medical Group
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
UNC Health Care System
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Duke Gastroenterology
Durham, North Carolina, United States, 22710
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Huntersville, North Carolina, United States, 28078
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States, 28557
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Piedmont Healthcare
Statesville, North Carolina, United States, 28677
Trial Management Associates
Wilmington, North Carolina, United States, 28403
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45249
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio, United States, 45249
University of Cincinnati Physicians Company , LLC
Cincinnati, Ohio, United States, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104-4017
United States, Pennsylvania
Drexel University, College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Temple University Health System
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
UPMC Montefiore
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Associates in Gastroenterology, PLC
Hermitage, Tennessee, United States, 37076
Methodist University Hospital
Memphis, Tennessee, United States, 38103
Quality Medical Research, PLLC
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Liver Center of Texas
Dallas, Texas, United States, 75234
Baylor All Saints Medical Center - Baylor Research Institute
Fort Worth, Texas, United States, 76104
DHAT Research Institute
Garland, Texas, United States, 75044
Baylor College of Medicine
Houston, Texas, United States, 77030
Liver Associates of Texas, P.A.
Houston, Texas, United States, 77030
Research Specialists of Texas
Houston, Texas, United States, 77030
Centex Studies Inc.
Houston, Texas, United States, 77058
Gulf Coast Research Group LLC
Houston, Texas, United States, 77098
Brooke Army Medical Center
Houston, Texas, United States, 78234
Gastroenterology Consultants of San Antonio
Live Oak, Texas, United States, 78233
Centex Studies Inc
McAllen, Texas, United States, 78504
Pinnacle Clinical Research, PLLC
Rollingwood, Texas, United States, 78746
The Texas Liver Institute, Inc.
San Antonio, Texas, United States, 78215
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States, 78229
Texas Digestive Consultants (TDDC)
Southlake, Texas, United States, 76092-9167
Victoria Gastroenterology
Victoria, Texas, United States, 77904
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Medical Campus - Center for Liver Disease
Falls Church, Virginia, United States, 22042
Bon Secours Liver Institute of Virginia - Newport News
Newport News, Virginia, United States, 23602
Bon Secours Liver Institute of Virginia - Richmond
Richmond, Virginia, United States, 23226
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Kaiser Permanente Springfield Medical Center
Springfield, Virginia, United States, 22150
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104-2420
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States, 98104
Argentina
Sanatorio Güemes
Caba, Buenos Aires, Argentina, 1180AAX
Axismed S.R.L
Caba, Buenos Aires, Argentina, C1430CKE
Instituto de Investigaciones Clinicas San Nicolas SRL
San Nicolas, Buenos Aires, Argentina, 2900
Hospital Alemán
Buenos Aires, Argentina, 1118
Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
Buenos Aires, Argentina, 1119
Fundación Sanatorio Güemes
Buenos Aires, Argentina, 1180
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1181
Hospital Británico de Buenos Aires
Buenos Aires, Argentina, 1280
CCBR Clinical Research
Buenos Aires, Argentina, 1430
Centro De Hepatologia Ciudad de La Plata
La Plata, Argentina, 1704
Hospital Universitario Austral
Pilar, Argentina, 1629
Dim Clinica Privada
Ramos Mejía, Argentina, 1704
Hospital Provincial del Centenario
Rosario, Argentina, 2000
Instituto Medico Alas
Salta, Argentina, A4400ERH
Australia
Flinders Medical Centre
Bedford Park, Australia, 5042
Box Hill Hospital
Box Hill, Australia, 3128
Monash Medical Centre Clayton
Clayton, Australia, 3168
Concord Repatriation General Hospital
Concord, Australia, 2139
St. Vincent's Hospital Melbourne
Fitzroy, Australia, 3065
Austin Hospital
Heidelberg, Australia, 3084
Nepean Hospital
Kingswood, Australia, 2747
The St George Hospital
Kogarah, Australia, 2217
The Alfred Hospital
Melbourne, Australia, 3004
Fiona Stanley Hospital
Murdoch, Australia, 6150
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Australia, 6009
Westmead Hospital
Westmead, Australia, 2145
Belgium
Hôpital Erasme
Bruxelles, Belgium, 1070
Universitair Ziekenhuis Brussel
Bruxelles, Belgium, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Centre Hospitalier de Wallonie Picardie (CHWAPI)
Tournai, Belgium, 7500
Canada, British Columbia
LAIR Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Western Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Canada, Quebec
Monteregie Centre de Recherche
Greenfield Park, Quebec, Canada, J4V 2H1
The Montreal Chest Institute
Montréal, Quebec, Canada, H4A 3J1
Canada
University of Calgary, Cumming School of Medicine
Calgary, AB, Canada, T2N 4Z6
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
Halifax, Canada, B3H 1V7
Mc Gill University Health Centre (MUHC)
Montreal, Canada, H4A 3J1
University of Manitoba
Winnipeg, MB, Canada, R3E 3P4
Chile
Hospital de La Serena
La Serena, Chile, 1710209
Alta Salud
Los Ángeles, Chile, 4430035
Hospital Clínico UC
Santiago, Chile, 8330024
Hospital Clínico Universidad de Chile
Santiago, Chile, 8380456
Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
Santiago, Chile, 8910108
Clínica Reñaca
Vina Del Mar, Chile, 2540488
Colombia
Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
Bogotá, Bogota D.C, Colombia, 110221
Fundación Cardio Infantil - Instituto de Cardiología
Bogotá, Colombia, 04073-5820
Fundación Valle del Lili
Cali, Colombia, 760032
Centro Medico Imbanaco
Cali, Colombia, 760042
Hospital Universitario San Vicente de Paul Fundación
Medellin, Colombia, 50010
Hospital Pablo Tobon Uribe
Medellin, Colombia, 50034
Fundacion Hospitalaria San Vicente de Paul
Medellín, Colombia, 050010
Czechia
Fakultní Nemocnice Brno
Brno, Czechia, 625 00
Research Site S.R.O.
Plzen, Czechia, 30100
Research Site, s.r.o
Plzen, Czechia, 30100
KlinMed s.r.o.
Praha 2, Czechia, 120 00
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
France
CHU Amiens Picardie
Amiens, France, 80054
CHU Angers
Angers, France, 49933
Hôpital Antoine-Béclère
Clamart, France, 92140
Hôpital Beaujon
Clichy, France, 92110
Hôpital Henri Mondor
Créteil, France, 94000
CHU Limoges - Hôpital Dupuytren
Limoges, France, 87042
Hôpital de la Croix-Rousse
Lyon, France, 69004
Hôpital Saint Joseph
Marseille, France, 13285
CHRU Montpellier- Hôpital Saint Eloi
Montpellier, France, 34295
CHU de Nantes - Hôpital Laennec
Nantes, France, 44093
CHU de Nice- Hôpital de l'Archet II
Nice, France, 06202
Hôpital Saint-Antoine
Paris, France, 75012
Hopital Pitie-Salpetriere
Paris, France, 75013
Hôpital Cochin
Paris, France, 75014
Hôpital Haut-Lévêque
Pessac, France, 33604
CHU Toulouse - Hôpital Purpan
Toulouse, France, 31059
CHU Nancy - Hôpital Brabois
Vandoeuvre Les Nancy, France, 54511
Hôpital Paul Brousse
Villejuif, France, 94800
Germany
Universitätsklinikum Köln
Köln, Northwest, Germany, 50937
Universitätsklinikum RWTH Aachen
Aachen, Germany, 52074
Liver Center
Berlin, Germany, 10969
Gastroenterologie am Bayerischen Platz/ Gastro-Studien
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Essen
Essen, Germany, 45147
Universitätsklinikum Frankfurt - Goethe Universität
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Medizinische Hochschule Hannover (MHH)
Hannover, Germany, 30625
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Köln
Köln, Germany, 50937
EUGASTRO GmbH
Leipzig, Germany, 04103
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90141
Policlinico Tor Vergata
Roma, Italy, 00133
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
San Giovanni Rotondo, Italy, 71013
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, Italy, 10126
Mexico
Hospital Angeles Clinica Londres
Mexico, DIF, Mexico, 6700
Centro de Investigación Clínica del Pacífico, S.A de C.V.
Acapulco, Mexico, 39670
Hospital Maria Auxiliadora
Guadalajara, Mexico
Médica Sur
Mexico City, Mexico, 14050
Consultorio Medico
Mexico City, Mexico
Accelerium S de RL de C.V.
Monterrey, Mexico
Netherlands
Vrije Universiteit Medical Center
Amsterdam, Netherlands, 1081 HZ
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Maastricht UMC+
Maastricht, Netherlands, 6229 HX
Radboud UMC
Nijmegen, Netherlands, 6525 GA
Portugal
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
Lisboa, Portugal, 1169-050
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisboa, Portugal, 1649-035
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, Portugal, 4200-319
Centro Hospitalar de São João
Porto, Portugal, 4200-319
Centro Hospita de Tras-os-Montes e Alto Douro, EPE
Vila Real, Portugal, 5000-508
Puerto Rico
Caparra Internal Medicine Research Center
Rio Grande, Puerto Rico, 00745
Klinical Investigations Group, LLC
San Juan, Puerto Rico, 00909
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Fundación de Investigación
San Juan, Puerto Rico, 909
Romania
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Romania, 021105
Institutul Clinic Fundeni
Bucharest, Romania, 022328
SC Cabinet Particular Policlinic Algomed SRL
Timisoara, Romania, 300002
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
Timisoara, Romania, 300736
Russian Federation
FSBRI "Federal Research Center of nutrition and biotechnology
Moscow, Russian Federation, 109240
I. M. Sechenov - First Moscow State Medical University
Moscow, Russian Federation, 119991
M. F. Vladimirsky - Clinical Research Institution of Moscow Region
Moscow, Russian Federation, 129110
Military medical academy n. a. S.M. Kirov
Saint Petersburg, Russian Federation, 194044
St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
Saint Petersburg, Russian Federation, 197110
City Clinical Hospital No. 31
St. Petersburg, Russian Federation, 197110
South Africa
Tiervlei Trial Centre
Cape Town, South Africa, 7530
Mediclinic Constantiaberg
Cape Town, South Africa, 7800
Phoenix Pharma (Pty) Ltd
Port Elizabeth, South Africa, 6001
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 8025
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 8035
Hospital Clinic i Provincial
Barcelona, Spain, 8036
Hospital Universitario 12 de Octubre
Madrid, Spain, 128041
Hospital Universitario Puerta de Hierro
Majadahonda, Spain, 28222
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain, 36071
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
Sevilla, Spain, 41014
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 14186
Switzerland
INSELSPITAL, University Hospital Bern
Bern, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Kantonsspital St. Gallen
Saint Gallen, Switzerland, 9007
UniversitätsSpital Zürich
Zurich, Switzerland, 8091
Turkey
Ankara Üniversitesi Tıp Fakültesi
Ankara, Turkey, 6100
Bezmiâlem Vakıf Üniversitesi
Fatih, Turkey, 34093
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
Istanbul, Turkey, 34766
Ege Üniversitesi
Izmir, Turkey, 35040
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Pendik, Turkey, 34890
Istanbul Universitesi Istanbul Tip Fakultesi
Çapa, Turkey, 34093
United Kingdom
University Hospitals Birmingham NHS foundation Trust
Birmingham, United Kingdom, B15 2TT
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Frimley Park Hospital NHS Foundation Trust
Frimley, United Kingdom, GU16 7UJ
Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Bart Health NHS Trust- Royal London Hospital
London, United Kingdom, E1 1BB
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
London, United Kingdom, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom, SE1 7EH
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, United Kingdom, SW170QT
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
Genfit
Investigators
Layout table for investigator information
Study Director: Pascal BIRMAN, MD Genfit
Layout table for additonal information
Responsible Party: Genfit
ClinicalTrials.gov Identifier: NCT02704403    
Other Study ID Numbers: GFT505-315-1
2015-005385-38 ( EudraCT Number )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: May 2020
Keywords provided by Genfit:
Elafibranor
NASH
Nonalcoholic steatohepatitis
Fatty liver disease
Fibrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases