Study Stopped
Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
RESOLVE-IT
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
2 other identifiers
interventional
2,157
25 countries
326
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Longer than P75 for phase_3
326 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedResults Posted
Study results publicly available
March 23, 2022
CompletedMarch 23, 2022
February 1, 2022
4.7 years
February 16, 2016
January 7, 2022
February 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
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.
Measurement at 72 weeks
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes
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.
From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)
Secondary Outcomes (7)
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
Measurements at 72 weeks
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
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
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
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
- +2 more secondary outcomes
Study Arms (2)
120 mg Elafibranor
EXPERIMENTALCoated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
Placebo
PLACEBO COMPARATORCoated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- +1 more criteria
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genfitlead
Study Sites (326)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
The Institute for Liver Health
Chandler, Arizona, 85224, United States
The Institute for Liver Health
Glendale, Arizona, 85306, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Dignity Health St. Joseph's Hospital
Phoenix, Arizona, 85013, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Institute for Liver Health
Tucson, Arizona, 85711, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
The University of Arizona College of Medicine Liver Research Institute
Tucson, Arizona, 85724-0001, United States
Liver Wellness Center
Little Rock, Arkansas, 72205, United States
GW Research, Inc.
Chula Vista, California, 91910, United States
Southern California Research Center
Coronado, California, 92118, United States
University of California, San Francisco, Fresno Community Regional Medical Center
Fresno, California, 93701-2302, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
University of California, San Francisco, Fresno Community Regional Medical Center
Fresno, California, 93721, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
University of California - San Diego
La Jolla, California, 92037, United States
Loma Linda University Medical Center - Transplantation Insitute
Loma Linda, California, 92354, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Gastrointestinal Biosciences Clinical Trials LLC
Los Angeles, California, 90067, United States
Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
Los Angeles, California, 90073, United States
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Alliance Clinical Research
Oceanside, California, 92056, United States
National Research Institute
Panorama City, California, 91402, United States
Alliance Clinical Research
Poway, California, 92064, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
University of California, San Diego Airway Research and Clinical Trials Center
San Diego, California, 92103, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
VA San Diego HealthCare System
San Diego, California, 92161, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Sutter West Bay Hospitals dba California Pacific Medical Center
San Francisco, California, 94115, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, 94143, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
Yale University School of Medicine, Section of Digestive Diseases
New Haven, Connecticut, 65200, United States
Georgetown University Hospitals
Washington D.C., District of Columbia, 20007, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Integrity Clinical Research LLC
Doral, Florida, 33166, United States
University of Florida
Gainesville, Florida, 32610, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Mayo Clinic Hospital
Jacksonville, Florida, 32224, United States
Florida Digestive Health Specialists, LLP
Lakewood Rch, Florida, 34211-4930, United States
Atlantic Gastroenterology Associates, LLC
Lakewood Rch, Florida, 34211, United States
Miami VA Healthcare System
Miami, Florida, 33125-1624, United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
South Florida Center of Gastroenterology, PA
Wellington, Florida, 33414, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Summit Clinical Research
Athens, Georgia, 30607, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Atlanta Medical Center, Inc.
Atlanta, Georgia, 30312, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060-8949, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital - Arkes Family Pavilion
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60637, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Gastroenterology Associates of Hazard
Hazard, Kentucky, 41701, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
University of Louisville Medical / Dental Complex
Louisville, Kentucky, 40202, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Kaiser Permanente Shady Grove Medical Center
Rockville, Maryland, 20850, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 06155, United States
Henry Ford Health System, Division of Gastroenterology & Hepatology
Detroit, Michigan, 48202, United States
Gastrointestinal Associates & Endoscopy Center
Flowood, Mississippi, 39232, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Luke's Liver Transplant & Specialist
Kansas City, Missouri, 64111, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63104, United States
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 89030, United States
Rutgers, New Jersey Medical School
Newark, New Jersey, 07103, United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109, United States
University at Buffalo, Clinical and Translational Research Center
Buffalo, New York, 14203, United States
Hofstra Northwell School of Medicine
Manhasset, New York, 11030, United States
Concorde Medical Group
New York, New York, 10016, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
New York-Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032, United States
Beth Israel Medical Center
New York, New York, 45267, United States
Premier Medical Group
Poughkeepsie, New York, 12601, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
UNC Health Care System
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Duke Gastroenterology
Durham, North Carolina, 22710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Huntersville, North Carolina, 28078, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, 28557, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Piedmont Healthcare
Statesville, North Carolina, 28677, United States
Trial Management Associates
Wilmington, North Carolina, 28403, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45249, United States
Ohio Gastroenterology & Liver Institute
Cincinnati, Ohio, 45249, United States
University of Cincinnati Physicians Company , LLC
Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104-4017, United States
Drexel University, College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Health System
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Associates in Gastroenterology, PLC
Hermitage, Tennessee, 37076, United States
Methodist University Hospital
Memphis, Tennessee, 38103, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Liver Center of Texas
Dallas, Texas, 75234, United States
Baylor All Saints Medical Center - Baylor Research Institute
Fort Worth, Texas, 76104, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Centex Studies Inc.
Houston, Texas, 77058, United States
Gulf Coast Research Group LLC
Houston, Texas, 77098, United States
Brooke Army Medical Center
Houston, Texas, 78234, United States
Gastroenterology Consultants of San Antonio
Live Oak, Texas, 78233, United States
Centex Studies Inc
McAllen, Texas, 78504, United States
Pinnacle Clinical Research, PLLC
Rollingwood, Texas, 78746, United States
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215, United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229, United States
Texas Digestive Consultants (TDDC)
Southlake, Texas, 76092-9167, United States
Victoria Gastroenterology
Victoria, Texas, 77904, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Medical Campus - Center for Liver Disease
Falls Church, Virginia, 22042, United States
Bon Secours Liver Institute of Virginia - Newport News
Newport News, Virginia, 23602, United States
Bon Secours Liver Institute of Virginia - Richmond
Richmond, Virginia, 23226, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Kaiser Permanente Springfield Medical Center
Springfield, Virginia, 22150, United States
Harborview Medical Center
Seattle, Washington, 98104-2420, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
Sanatorio Güemes
Caba, Buenos Aires, 1180AAX, Argentina
Axismed S.R.L
CABA, Buenos Aires, C1430CKE, Argentina
Instituto de Investigaciones Clinicas San Nicolas SRL
San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina
Hospital Alemán
Buenos Aires, 1118, Argentina
Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
Buenos Aires, 1119, Argentina
Fundación Sanatorio Güemes
Buenos Aires, 1180, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, 1181, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, 1280, Argentina
CCBR Clinical Research
Buenos Aires, 1430, Argentina
Centro De Hepatologia Ciudad de La Plata
La Plata, 1704, Argentina
Hospital Universitario Austral
Pilar, 1629, Argentina
Dim Clinica Privada
Ramos Mejía, 1704, Argentina
Hospital Provincial del Centenario
Rosario, 2000, Argentina
Instituto Medico Alas
Salta, A4400ERH, Argentina
Flinders Medical Centre
Bedford Park, 5042, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Monash Medical Centre Clayton
Clayton, 3168, Australia
Concord Repatriation General Hospital
Concord, 2139, Australia
St. Vincent's Hospital Melbourne
Fitzroy, 3065, Australia
Austin Hospital
Heidelberg, 3084, Australia
Nepean Hospital
Kingswood, 2747, Australia
The St George Hospital
Kogarah, 2217, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Sir Charles Gairdner Hospital (SCGH)
Nedlands, 6009, Australia
Westmead Hospital
Westmead, 2145, Australia
Hôpital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier de Wallonie Picardie (CHWAPI)
Tournai, 7500, Belgium
LAIR Centre
Vancouver, British Columbia, V5Z 1H2, Canada
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Western Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Monteregie Centre de Recherche
Greenfield Park, Quebec, J4V 2H1, Canada
The Montreal Chest Institute
Montreal, Quebec, H4A 3J1, Canada
University of Calgary, Cumming School of Medicine
Calgary, AB, T2N 4Z6, Canada
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
Halifax, B3H 1V7, Canada
Mc Gill University Health Centre (MUHC)
Montreal, H4A 3J1, Canada
University of Manitoba
Winnipeg, MB, R3E 3P4, Canada
Hospital de La Serena
La Serena, 1710209, Chile
Alta Salud
Los Ángeles, 4430035, Chile
Hospital Clínico UC
Santiago, 8330024, Chile
Hospital Clínico Universidad de Chile
Santiago, 8380456, Chile
Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
Santiago, 8910108, Chile
Clínica Reñaca
Viña del Mar, 2540488, Chile
Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
Bogotá, Bogota D.C., 110221, Colombia
Fundación Cardio Infantil - Instituto de Cardiología
Bogotá, 04073-5820, Colombia
Fundación Valle del Lili
Cali, 760032, Colombia
Centro Medico Imbanaco
Cali, 760042, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, 050010, Colombia
Hospital Universitario San Vicente de Paul Fundación
Medellín, 50010, Colombia
Hospital Pablo Tobon Uribe
Medellín, 50034, Colombia
Fakultní Nemocnice Brno
Brno, 625 00, Czechia
Research Site S.R.O.
Pilsen, 30100, Czechia
Research Site, s.r.o
Pilsen, 30100, Czechia
KlinMed s.r.o.
Prague, 120 00, Czechia
Aarhus University Hospital
Aarhus, 8000, Denmark
Helsinki University Central Hospital
Helsinki, 00029, Finland
CHU Amiens Picardie
Amiens, 80054, France
CHU Angers
Angers, 49933, France
Hôpital Antoine-Béclère
Clamart, 92140, France
Hôpital Beaujon
Clichy, 92110, France
Hôpital Henri Mondor
Créteil, 94000, France
CHU Limoges - Hôpital Dupuytren
Limoges, 87042, France
Hôpital de la Croix-Rousse
Lyon, 69004, France
Hôpital Saint Joseph
Marseille, 13285, France
CHRU Montpellier- Hôpital Saint Eloi
Montpellier, 34295, France
CHU de Nantes - Hôpital Laennec
Nantes, 44093, France
CHU de Nice- Hôpital de l'Archet II
Nice, 06202, France
Hôpital Saint-Antoine
Paris, 75012, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
Hôpital Haut-Lévêque
Pessac, 33604, France
CHU Toulouse - Hôpital Purpan
Toulouse, 31059, France
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54511, France
Hôpital Paul Brousse
Villejuif, 94800, France
Universitätsklinikum Köln
Cologne, Northwest, 50937, Germany
Universitätsklinikum RWTH Aachen
Aachen, 52074, Germany
Liver Center
Berlin, 10969, Germany
Gastroenterologie am Bayerischen Platz/ Gastro-Studien
Berlin, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinikum Köln
Cologne, 50937, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Universitätsklinikum Frankfurt - Goethe Universität
Frankfurt, 60590, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
EUGASTRO GmbH
Leipzig, 04103, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Universitätsklinikum Magdeburg
Magdeburg, 39120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90141, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126, Italy
Hospital Angeles Clinica Londres
México, DIF, 6700, Mexico
Centro de Investigación Clínica del Pacífico, S.A de C.V.
Acapulco, 39670, Mexico
Hospital Maria Auxiliadora
Guadalajara, Mexico
Médica Sur
Mexico City, 14050, Mexico
Consultorio Medico
Mexico City, Mexico
Accelerium S de RL de C.V.
Monterrey, Mexico
Vrije Universiteit Medical Center
Amsterdam, 1081 HZ, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Maastricht UMC+
Maastricht, 6229 HX, Netherlands
Radboud UMC
Nijmegen, 6525 GA, Netherlands
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
Lisbon, 1169-050, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319, Portugal
Centro Hospitalar de São João
Porto, 4200-319, Portugal
Centro Hospita de Tras-os-Montes e Alto Douro, EPE
Vila Real, 5000-508, Portugal
Caparra Internal Medicine Research Center
Río Grande, 00745, Puerto Rico
Klinical Investigations Group, LLC
San Juan, 00909, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Fundación de Investigación
San Juan, 909, Puerto Rico
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, 021105, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
SC Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002, Romania
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
Timișoara, 300736, Romania
FSBRI "Federal Research Center of nutrition and biotechnology
Moscow, 109240, Russia
I. M. Sechenov - First Moscow State Medical University
Moscow, 119991, Russia
M. F. Vladimirsky - Clinical Research Institution of Moscow Region
Moscow, 129110, Russia
Military medical academy n. a. S.M. Kirov
Saint Petersburg, 194044, Russia
City Clinical Hospital No. 31
Saint Petersburg, 197110, Russia
St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
Saint Petersburg, 197110, Russia
Tiervlei Trial Centre
Cape Town, 7530, South Africa
Mediclinic Constantiaberg
Cape Town, 7800, South Africa
Phoenix Pharma (Pty) Ltd
Port Elizabeth, 6001, South Africa
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 8035, Spain
Hospital Clinic i Provincial
Barcelona, 8036, Spain
Hospital Universitario 12 de Octubre
Madrid, 128041, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, 36071, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
Seville, 41014, Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, 14186, Sweden
INSELSPITAL, University Hospital Bern
Bern, 3010, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Ankara Üniversitesi Tıp Fakültesi
Ankara, 6100, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Çapa, 34093, Turkey (Türkiye)
Bezmiâlem Vakıf Üniversitesi
Fatih, 34093, Turkey (Türkiye)
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
Istanbul, 34766, Turkey (Türkiye)
Ege Üniversitesi
Izmir, 35040, Turkey (Türkiye)
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Pendik, 34890, Turkey (Türkiye)
University Hospitals Birmingham NHS foundation Trust
Birmingham, B15 2TT, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Frimley, GU16 7UJ, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Bart Health NHS Trust- Royal London Hospital
London, E1 1BB, United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 7EH, United Kingdom
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, SW170QT, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated based upon limited efficacy at time of the interim analysis, not due to safety concerns, and the conclusion that there would be limited benefit for participants to continue in the trial. Therefore, the results for efficacy endpoints other than the primary and key secondary endpoints are not presented in the disclosure of these results.
Results Point of Contact
- Title
- Carol Addy, MD MMSc
- Organization
- GENFIT
Study Officials
- STUDY DIRECTOR
Carol Addy, MD MMSc
Genfit
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
March 10, 2016
Study Start
March 1, 2016
Primary Completion
October 28, 2020
Study Completion
October 28, 2020
Last Updated
March 23, 2022
Results First Posted
March 23, 2022
Record last verified: 2022-02