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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02704403
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : April 1, 2019
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

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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 : December 2021


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 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

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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


Contacts
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Contact: GENFIT clinicaltrial@genfit.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Digestive Health Specialists of the Southeast Recruiting
Dothan, Alabama, United States, 36305
United States, Arizona
The Institute for Liver Health Recruiting
Chandler, Arizona, United States, 85224
The Institute for Liver Health Recruiting
Glendale, Arizona, United States, 85306
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Dignity Health St. Joseph's Hospital Recruiting
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054
Adobe Clinical Research, LLC Recruiting
Tucson, Arizona, United States, 85712
The University of Arizona College of Medicine Liver Research Institute Recruiting
Tucson, Arizona, United States, 85724-0001
United States, Arkansas
Liver Wellness Center Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
GW Research, Inc. Recruiting
Chula Vista, California, United States, 91910
Southern California Research Center Recruiting
Coronado, California, United States, 92118
Fresno Clinical Research Center Recruiting
Fresno, California, United States, 93720
University of California, San Francisco, Fresno Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Scripps Clinic Torrey Pines Recruiting
La Jolla, California, United States, 92037
University of California - San Diego Recruiting
La Jolla, California, United States, 92037
Loma Linda University Medical Center - Transplantation Insitute Recruiting
Loma Linda, California, United States, 92354
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Keck Hospital of USC Recruiting
Los Angeles, California, United States, 90033
Ruane Clinical Research Group Inc. Recruiting
Los Angeles, California, United States, 90036
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Gastrointestinal Biosciences Clinical Trials LLC Recruiting
Los Angeles, California, United States, 90067
Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center Recruiting
Los Angeles, California, United States, 90073
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
National Research Institute Recruiting
Panorama City, California, United States, 91402
Alliance Clinical Research Recruiting
Poway, California, United States, 92064
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States, 92123
VA San Diego HealthCare System Recruiting
San Diego, California, United States, 92161
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Sutter West Bay Hospitals dba California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
University of California, San Francisco, Medical Center at Parnassus Recruiting
San Francisco, California, United States, 94143
Ventura Clinical Trials Recruiting
Ventura, California, United States, 93003
United States, Colorado
South Denver Gastroenterology Recruiting
Englewood, Colorado, United States, 80113
United States, Connecticut
Yale University SCHOOL OF MEDICINE, SECTION OF DIGESTIVE DISEASES Recruiting
New Haven, Connecticut, United States, 65200
United States, District of Columbia
Georgetown University Hospitals Recruiting
Washington, District of Columbia, United States, 20007
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
Excel Medical Clinical Trials LLC Recruiting
Boca Raton, Florida, United States, 33434
Integrity Clinical Research LLC Recruiting
Doral, Florida, United States, 33166
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Nature Coast Clinical Research Recruiting
Inverness, Florida, United States, 34452
Mayo Clinic Hospital Recruiting
Jacksonville, Florida, United States, 32224
Atlantic Gastroenterology Associates, LLC Recruiting
Lakewood Ranch, Florida, United States, 34211
University of Miami - Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
University of Miami - Schiff Center for Liver Diseases Recruiting
Miami, Florida, United States, 33136
South Florida Center of Gastroenterology, PA Recruiting
Wellington, Florida, United States, 33414
Florida Medical Clinic, PA Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Summit Clinical Research Recruiting
Athens, Georgia, United States, 30607
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Atlanta Medical Center, Inc. Recruiting
Atlanta, Georgia, United States, 30312
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern Memorial Hospital - Arkes Family Pavilion Recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Loyola University Chicago Recruiting
Maywood, Illinois, United States, 60153
United States, Kentucky
Gastroenterology Associates of Hazard Recruiting
Hazard, Kentucky, United States, 41701
University of Kentucky Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
University of Louisville Medical / Dental Complex Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Louisiana Research Center, LLC Recruiting
Shreveport, Louisiana, United States, 71105
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Kaiser Permanente Shady Grove Medical Center Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center (BIDMC) Recruiting
Boston, Massachusetts, United States, 02215
University of Massachusetts Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 06155
United States, Michigan
Henry Ford Health System, Division of Gastroenterology & Hepatology Recruiting
Detroit, Michigan, United States, 48202
United States, Mississippi
Gastrointestinal Associates & Endoscopy Center Recruiting
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Liver Transplant & Specialist Recruiting
Kansas City, Missouri, United States, 64111
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Kansas City Research Institute Recruiting
Kansas City, Missouri, United States, 64131
Saint Louis University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Amici Clinical Research LLC Not yet recruiting
Martinsville, New Jersey, United States, 08836
Rutgers, Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 89030
Rutgers, New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
United States, New Mexico
Southwest Gastroenterology Associates Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
University at Buffalo, Clinical and Translational Research Center Recruiting
Buffalo, New York, United States, 14203
Hofstra Northwell School of Medicine Recruiting
Manhasset, New York, United States, 11030
Concorde Medical Group Recruiting
New York, New York, United States, 10016
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
New York-Presbyterian Hospital - Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Beth Israel Medical Center Recruiting
New York, New York, United States, 45267
Premier Medical Group Recruiting
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Asheville Gastroenterology Associates Recruiting
Asheville, North Carolina, United States, 28801
UNC Health Care System Recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Duke Gastroenterology Recruiting
Durham, North Carolina, United States, 22710
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States, 28304
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Piedmont Healthcare Recruiting
Statesville, North Carolina, United States, 28677
Trial Management Associates Recruiting
Wilmington, North Carolina, United States, 28403
United States, Ohio
Ohio Gastroenterology & Liver Institute Recruiting
Cincinnati, Ohio, United States, 45249
University of Cincinnati Physicians Company , LLC Recruiting
Cincinnati, Ohio, United States, 45267
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Options Health Research, LLC Recruiting
Tulsa, Oklahoma, United States, 74104-4017
United States, Pennsylvania
Drexel University, College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Temple University Health System Recruiting
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
UPMC Montefiore Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Ralph H. Johnson VA Medical Center Recruiting
Charleston, South Carolina, United States, 29401
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Associates in Gastroenterology, PLC Recruiting
Hermitage, Tennessee, United States, 37076
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38103
Quality Medical Research, PLLC Recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Liver Center of Texas Recruiting
Dallas, Texas, United States, 75234
Baylor All Saints Medical Center - Baylor Research Institute Recruiting
Fort Worth, Texas, United States, 76104
DHAT Research Institute Recruiting
Garland, Texas, United States, 75044
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Liver Associates of Texas, P.A. Recruiting
Houston, Texas, United States, 77030
Research Specialists of Texas Recruiting
Houston, Texas, United States, 77030
Centex Studies Inc. Recruiting
Houston, Texas, United States, 77058
Gulf Coast Research Group LLC Recruiting
Houston, Texas, United States, 77098
Brooke Army Medical Center Recruiting
Houston, Texas, United States, 78234
Gastroenterology Consultants of San Antonio Recruiting
Live Oak, Texas, United States, 78233
Centex Studies Inc Recruiting
McAllen, Texas, United States, 78504
Pinnacle Clinical Research, PLLC Recruiting
Rollingwood, Texas, United States, 78746
The Texas Liver Institute, Inc. Recruiting
San Antonio, Texas, United States, 78215
Texas Digestive Consultants (TDDC) Recruiting
Southlake, Texas, United States, 76092-9167
Victoria Gastroenterology Recruiting
Victoria, Texas, United States, 77904
United States, Utah
University of Utah School of Medicine Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Inova Fairfax Medical Campus - Center for Liver Disease Recruiting
Falls Church, Virginia, United States, 22042
Bon Secours Liver Institute of Virginia - Newport News Recruiting
Newport News, Virginia, United States, 23602
Bon Secours Liver Institute of Virginia - Richmond Recruiting
Richmond, Virginia, United States, 23226
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Kaiser Permanente Springfield Medical Center Recruiting
Springfield, Virginia, United States, 22150
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104-2420
Swedish Organ Transplant and Liver Center Recruiting
Seattle, Washington, United States, 98104
Argentina
Sanatorio Güemes Recruiting
Caba, Buenos Aires, Argentina, 1180AAX
Axismed S.R.L Recruiting
Caba, Buenos Aires, Argentina, C1430CKE
Instituto de Investigaciones Clinicas San Nicolas SRL Recruiting
San Nicolas, Buenos Aires, Argentina, 2900
Hospital Alemán Recruiting
Buenos Aires, Argentina, 1118
Centro de Investigación y Prevención Cardiovascular SA (CIPREC) Recruiting
Buenos Aires, Argentina, 1119
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, 1181
Hospital Británico de Buenos Aires Recruiting
Buenos Aires, Argentina, 1280
Centro De Hepatologia Ciudad de La Plata Recruiting
La Plata, Argentina, 1704
Hospital Universitario Austral Recruiting
Pilar, Argentina, 1629
Dim Clinica Privada Recruiting
Ramos Mejía, Argentina, 1704
Hospital Provincial del Centenario Recruiting
Rosario, Argentina, 2000
Instituto Medico Alas Recruiting
Salta, Argentina, A4400ERH
Australia
Flinders Medical Centre Recruiting
Bedford Park, Australia, 5042
Box Hill Hospital Recruiting
Boxhill, Australia, 3128
Monash Medical Centre Clayton Recruiting
Clayton, Australia, 3168
Concord Repatriation General Hospital Recruiting
Concord, Australia, 2139
St. Vincent's Hospital Melbourne Recruiting
Fitzroy, Australia, 3065
Austin Hospital Recruiting
Heidelberg, Australia, 3084
Nepean Hospital Recruiting
Kingswood, Australia, 2747
The St George Hospital Recruiting
Kogarah, Australia, 2217
The Alfred Hospital Recruiting
Melbourne, Australia, 3004
Fiona Stanley Hospital Recruiting
Murdoch, Australia, 6150
Sir Charles Gairdner Hospital (SCGH) Recruiting
Nedlands, Australia, 6009
Westmead Hospital Recruiting
Westmead, Australia, 2145
Belgium
Hôpital Erasme Recruiting
Bruxelles, Belgium, 1070
Universitair Ziekenhuis Brussel Recruiting
Bruxelles, Belgium, 1090
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Universitair Ziekenhuis Leuven Recruiting
Leuven, Belgium, 3000
Centre Hospitalier de Wallonie Picardie (CHWAPI) Recruiting
Tournai, Belgium, 7500
Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Not yet recruiting
Belo Horizonte, Brazil, 30130-100
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, Brazil, 90035-903
Instituto do Fígado e Transplantes de Pernambuco Not yet recruiting
Recife, Brazil, 50100-130
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Not yet recruiting
Ribeirão Preto, Brazil, 14048-900
Hospital Universitário Clementino Fraga Filho (HUCFF) Not yet recruiting
Rio de Janeiro, Brazil, 21941-590
Universidade Federal da Bahia - Hospital Universitário Professor Edgard Santos (HUPES) Not yet recruiting
Salvador, Brazil, 40110-060
Faculdade de Medicina de São Jose do Rio Preto Not yet recruiting
Sao Jose do Rio Preto, Brazil, 15090-000
Hospital Sírio-Libanês Not yet recruiting
São Paulo, Brazil, 01308-050
Universidade Federal de São Paulo - UNIFESP Not yet recruiting
São Paulo, Brazil, 04021-001
Faculdade de Medicina da Universidade de São Paulo Not yet recruiting
São Paulo, Brazil, 05403-000
Canada
Dr John Farley Inc Not yet recruiting
Abbottsford, Canada, V6A 4B6
University of Calgary, Cumming School of Medicine Recruiting
Calgary, AB, Canada, T2N 4Z6
Queen Elizabeth Ii Health Sciences Centre, Nova Scotia Health Authority Recruiting
Halifax, Canada, B3H 1V7
McGill University Health Centre (MUHC) Recruiting
Montreal, Canada, H4A 3J1
Toronto Western Hospital Recruiting
Toronto, ON, Canada, M5G 2C4
Toronto Liver Centre Recruiting
Toronto, ON, Canada, M6H 3M1
LAIR Centre Recruiting
Vancouver, BC, Canada, V5Z 1H2
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre Recruiting
Vancouver, BC, Canada, V5Z 1M9
Dr John Farley Inc Not yet recruiting
Vancouver, BC, Canada, V6A 4B6
University of Manitoba Recruiting
Winnipeg, MB, Canada, R3E 3P4
Chile
Hospital de La Serena Recruiting
La Serena, Chile, 1710209
Alta Salud Recruiting
Los Ángeles, Chile, 4430035
Hospital Clínico UC Recruiting
Santiago, Chile, 8330024
Hospital Clínico Universidad de Chile Recruiting
Santiago, Chile, 8380456
Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment) Recruiting
Santiago, Chile, 8910108
Clínica Reñaca Recruiting
Vina Del Mar, Chile, 2540488
Colombia
Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO Recruiting
Bogota D.C, Colombia, 110221
Fundación Cardio Infantil - Instituto de Cardiología Recruiting
Bogotá, Colombia, 04073-5820
Fundación Santa Fe de Bogotá Centro de Estudios e Investigación en Salud (CEIS) Not yet recruiting
Bogotá, Colombia
Centro Medico Imbanaco Recruiting
Cali, Colombia
Fundación Valle del Lili Recruiting
Cali, Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Colombia
Hospital Universitario de San Vicente Fundación Not yet recruiting
Medellin, Colombia
Fundacion Hospitalaria San Vicente de Paul Recruiting
Medellín, Colombia, 050010
Czechia
Fakultní Nemocnice Brno Recruiting
Brno, Czechia, 625 00
Research Site, s.r.o Recruiting
Plzen, Czechia, 30100
KlinMed s.r.o. Recruiting
Praha 2, Czechia, 120 00
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
France
CHU Amiens Picardie Recruiting
Amiens, France, 80054
CHU Angers Recruiting
Angers, France, 49933
Hôpital Antoine-Béclère Recruiting
Clamart, France, 92140
Hôpital Beaujon Recruiting
Clichy, France, 92110
Hôpital Henri Mondor Recruiting
Créteil, France, 94000
CHU Limoges - Hôpital Dupuytren Recruiting
Limoges, France, 87042
Hôpital de la Croix-Rousse Recruiting
Lyon, France, 69004
Hôpital Saint Joseph Recruiting
Marseille, France, 13285
CHRU Montpellier- Hôpital Saint Eloi Recruiting
Montpellier, France, 34295
CHU de Nantes - Hôpital Laennec Recruiting
Nantes, France, 44093
CHU de Nice- Hôpital de l'Archet II Recruiting
Nice, France, 06202
Hôpital Saint-Antoine Recruiting
Paris, France, 75012
Hopital Pitie-Salpetriere Recruiting
Paris, France, 75013
Hôpital Cochin Recruiting
Paris, France, 75014
Hôpital Haut-Lévêque Recruiting
Pessac, France, 33604
CHU Toulouse - Hôpital Purpan Recruiting
Toulouse, France, 31059
CHU Nancy - Hôpital Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Hôpital Paul Brousse Recruiting
Villejuif, France, 94800
Germany
Universitätsklinikum RWTH Aachen Recruiting
Aachen, Germany, 52074
Liver Center Recruiting
Berlin, Germany, 10969
Gastroenterologie am Bayerischen Platz/ Gastro-Studien Recruiting
Berlin, Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
Universitätsklinikum Frankfurt - Goethe Universität Recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Universitätsklinikum Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20246
Medizinische Hochschule Hannover (MHH) Recruiting
Hannover, Germany, 30625
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
EUGASTRO GmbH Recruiting
Leipzig, Germany, 04103
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Universitätsklinikum Magdeburg Recruiting
Magdeburg, Germany, 39120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Recruiting
Palermo, Italy, 90127
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Recruiting
Palermo, Italy, 90141
Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Fondazione Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Ospedale Casa Sollievo della Sofferenza I.R.C.C.S. Recruiting
San Giovanni Rotondo, Italy, 71013
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette Recruiting
Torino, Italy, 10126
Mexico
Centro de Investigación Clínica del Pacífico, S.A de C.V. Recruiting
Acapulco, Mexico, 39670
Hospital Maria Auxiliadora Recruiting
Guadalajara, Mexico
Médica Sur Recruiting
Mexico City, Mexico, 14050
Consultorio Medico Recruiting
Mexico City, Mexico
Accelerium S de RL de C.V. Recruiting
Monterrey, Mexico
Netherlands
Vrije Universiteit Medical Center Recruiting
Amsterdam, Netherlands, 1081 HZ
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Maastricht UMC+ Recruiting
Maastricht, Netherlands, 6229 HX
Radboud UMC Recruiting
Nijmegen, Netherlands, 6525 GA
Portugal
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra Recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos Recruiting
Lisboa, Portugal, 1169-050
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria Recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de São João, EPE - Hospital de São João Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de São João Recruiting
Porto, Portugal, 4200-319
Centro Hospita de Tras-os-Montes e Alto Douro, EPE Recruiting
Vila Real, Portugal, 5000-508
Puerto Rico
Caparra Internal Medicine Research Center Recruiting
Rio Grande, Puerto Rico, 00745
Klinical Investigations Group, LLC Recruiting
San Juan, Puerto Rico, 00909
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico, 00927
Romania
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Recruiting
Bucharest, Romania, 021105
Institutul Clinic Fundeni Recruiting
Bucharest, Romania, 022328
SC Cabinet Particular Policlinic Algomed SRL Recruiting
Timisoara, Romania, 300002
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara Recruiting
Timisoara, Romania, 300736
Russian Federation
FSBRI "Federal Research Center of nutrition and biotechnology Recruiting
Moscow, Russian Federation, 109240
I. M. Sechenov - First Moscow State Medical University Recruiting
Moscow, Russian Federation, 119991
M. F. Vladimirsky - Clinical Research Institution of Moscow Region Recruiting
Moscow, Russian Federation, 129110
Military medical academy n. a. S.M. Kirov Recruiting
Saint Petersburg, Russian Federation, 194044
St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31 Recruiting
Saint Petersburg, Russian Federation, 197110
City Clinical Hospital No. 31 Not yet recruiting
St. Petersburg, Russian Federation, 197110
South Africa
Tiervlei Trial Centre Recruiting
Cape Town, South Africa, 7530
Mediclinic Constantiaberg Recruiting
Cape Town, South Africa, 7800
Phoenix Pharma (Pty) Ltd Recruiting
Port Elizabeth, South Africa, 6001
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 8025
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Hospital Clinic i Provincial Recruiting
Barcelona, Spain, 8036
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 128041
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Spain, 28222
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Complexo Hospitalario Universitario de Pontevedra Recruiting
Pontevedra, Spain, 36071
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Spain, 39008
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS) Recruiting
Sevilla, Spain, 41014
Sweden
Karolinska Universitetssjukhuset Huddinge Recruiting
Stockholm, Sweden, 14186
Switzerland
INSELSPITAL, University Hospital Bern Recruiting
Bern, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois (CHUV) Not yet recruiting
Lausanne, Switzerland, 1011
Kantonsspital St. Gallen Recruiting
Saint Gallen, Switzerland, 9007
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland, 8091
Turkey
Ankara Üniversitesi Tıp Fakültesi Recruiting
Ankara, Turkey, 6100
Istanbul Universitesi Istanbul Tip Fakultesi Recruiting
Capa/Istanbul, Turkey, 34093
Bezmiâlem Vakıf Üniversitesi Recruiting
Fatih Istanbul, Turkey, 34093
Ege Üniversitesi Recruiting
Izmir, Turkey, 35040
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi Recruiting
Pendik Istanbul, Turkey, 34890
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi Recruiting
Umraniye /Istanbul, Turkey, 34766
United Kingdom
University Hospitals Birmingham NHS foundation Trust Recruiting
Birmingham, United Kingdom, B15 2TT
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Frimley Park Hospital NHS Foundation Trust Recruiting
Frimley, United Kingdom, GU16 7UJ
The Royal Surrey County Hospital NHS Foundation Trust Not yet recruiting
Guildford, United Kingdom, GU2 7XX
Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Bart Health NHS Trust- Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
The Royal Free London NHS Foundation Trust - The Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
St George's University Hospitals NHS Foundation Trust - St George's Hospital Recruiting
London, United Kingdom, SW170QT
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre Recruiting
Nottingham, United Kingdom, NG7 2UH
Plymouth Hospitals NHS Trust - Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital Recruiting
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     History of Changes
Other Study ID Numbers: GFT505-315-1
2015-005385-38 ( EudraCT Number )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
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