Clinical trial NCT02704403: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Keywords: Elafibranor
NASH
Nonalcoholic steatohepatitis
Fatty liver disease
Fibrosis
Lead sponsor: Genfit
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 2157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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. 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:

   1. Cessation of menses for at least 12 months due to ovarian failure,
   2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
   3. 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)
   4. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
   5. 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.
4. 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).
5. NAS score ≥4.
6. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
7. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
8. 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:

   1. 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.
   2. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).

Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.

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 during the Screening Period despite optimal antihypertensive therapy
4. Type 1 diabetes participants .
5. Participants with decompensated diabetes (HbA1c\>9%).
6. Participants 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. Participants 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.
17. Participants with biological criteria exclusion as per effective protocol

Primary outcomes:
measure: Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
timeFrame: Measurement at 72 weeks
measure: Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes
timeFrame: 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:
measure: Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
timeFrame: Measurements at 72 weeks
measure: Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
timeFrame: Measurements after 72 weeks of treatment and up to study termination
measure: Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
timeFrame: Measurements after 72 weeks of treatment and up to study termination
measure: Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
timeFrame: Measurements after 72 weeks of treatment and up to study termination
measure: 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
timeFrame: Measurements after 72 weeks of treatment and up to study termination
measure: Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
timeFrame: Measurements after 72 weeks of treatment and up to study termination
measure: Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
timeFrame: Measurements after 72 weeks of treatment and up to study termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Glendale
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health St. Joseph's Hospital
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Tucson
country: United States
facility: Institute for Liver Health
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona College of Medicine Liver Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Fresno
country: United States
facility: University of California, San Francisco, Fresno Community Regional Medical Center
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: Fresno
country: United States
facility: University of California, San Francisco, Fresno Community Regional Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center - Transplantation Insitute
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Gastrointestinal Biosciences Clinical Trials LLC
state: California
city: Los Angeles
country: United States
facility: Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Veterans Affairs Greater Los Angeles Healthcare System
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: Poway
country: United States
facility: Alliance Clinical Research
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego Airway Research and Clinical Trials Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Diego
country: United States
facility: VA San Diego HealthCare System
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Francisco
country: United States
facility: Sutter West Bay Hospitals dba California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco, Medical Center at Parnassus
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine, Section of Digestive Diseases
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospitals
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials LLC
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Digestive Health Specialists, LLP
state: Florida
city: Lakewood Ranch
country: United States
facility: Atlantic Gastroenterology Associates, LLC
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Miami
country: United States
facility: University of Miami - Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami - Schiff Center for Liver Diseases
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, PA
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Athens
country: United States
facility: Summit Clinical Research
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Medical Center, Inc.
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Memorial Hospital - Arkes Family Pavilion
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Medical / Dental Complex
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Rockville
country: United States
facility: Kaiser Permanente Shady Grove Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System, Division of Gastroenterology & Hepatology
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates & Endoscopy Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Liver Transplant & Specialist
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: Rutgers, New Jersey Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest Gastroenterology Associates
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo, Clinical and Translational Research Center
state: New York
city: Manhasset
country: United States
facility: Hofstra Northwell School of Medicine
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital - Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Health Care System
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke Gastroenterology
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Ohio Gastroenterology & Liver Institute
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company , LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University, College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Montefiore
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Hermitage
country: United States
facility: Associates in Gastroenterology, PLC
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center - Baylor Research Institute
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Centex Studies Inc.
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group LLC
state: Texas
city: Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Live Oak
country: United States
facility: Gastroenterology Consultants of San Antonio
state: Texas
city: McAllen
country: United States
facility: Centex Studies Inc
state: Texas
city: Rollingwood
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute, Inc.
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Consultants (TDDC)
state: Texas
city: Victoria
country: United States
facility: Victoria Gastroenterology
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus - Center for Liver Disease
state: Virginia
city: Newport News
country: United States
facility: Bon Secours Liver Institute of Virginia - Newport News
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia - Richmond
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Springfield
country: United States
facility: Kaiser Permanente Springfield Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Organ Transplant and Liver Center
state: Washington
city: Caba
country: Argentina
facility: Sanatorio Güemes
state: Buenos Aires
city: Caba
country: Argentina
facility: Axismed S.R.L
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Instituto de Investigaciones Clinicas San Nicolas SRL
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Alemán
city: Buenos Aires
country: Argentina
facility: Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
city: Buenos Aires
country: Argentina
facility: Fundación Sanatorio Güemes
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Buenos Aires
country: Argentina
facility: CCBR Clinical Research
city: La Plata
country: Argentina
facility: Centro De Hepatologia Ciudad de La Plata
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Ramos Mejía
country: Argentina
facility: Dim Clinica Privada
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Salta
country: Argentina
facility: Instituto Medico Alas
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Kingswood
country: Australia
facility: Nepean Hospital
city: Kogarah
country: Australia
facility: The St George Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital (SCGH)
city: Westmead
country: Australia
facility: Westmead Hospital
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picardie (CHWAPI)
city: Vancouver
country: Canada
facility: LAIR Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Monteregie Centre de Recherche
state: Quebec
city: Montréal
country: Canada
facility: The Montreal Chest Institute
state: Quebec
city: Calgary, AB
country: Canada
facility: University of Calgary, Cumming School of Medicine
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
city: Montreal
country: Canada
facility: Mc Gill University Health Centre (MUHC)
city: Winnipeg, MB
country: Canada
facility: University of Manitoba
city: La Serena
country: Chile
facility: Hospital de La Serena
city: Los Ángeles
country: Chile
facility: Alta Salud
city: Santiago
country: Chile
facility: Hospital Clínico UC
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
city: Vina Del Mar
country: Chile
facility: Clínica Reñaca
city: Bogotá
country: Colombia
facility: Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
state: Bogota D.C
city: Bogotá
country: Colombia
facility: Fundación Cardio Infantil - Instituto de Cardiología
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Medellin
country: Colombia
facility: Hospital Universitario San Vicente de Paul Fundación
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Medellín
country: Colombia
facility: Fundacion Hospitalaria San Vicente de Paul
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Plzen
country: Czechia
facility: Research Site S.R.O.
city: Plzen
country: Czechia
facility: Research Site, s.r.o
city: Praha 2
country: Czechia
facility: KlinMed s.r.o.
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Clamart
country: France
facility: Hôpital Antoine-Béclère
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: CHRU Montpellier- Hôpital Saint Eloi
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Laennec
city: Nice
country: France
facility: CHU de Nice- Hôpital de l'Archet II
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpan
city: Vandoeuvre Les Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Northwest
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen
city: Berlin
country: Germany
facility: Liver Center
city: Berlin
country: Germany
facility: Gastroenterologie am Bayerischen Platz/ Gastro-Studien
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt - Goethe Universität
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
city: Mexico
country: Mexico
facility: Hospital Angeles Clinica Londres
state: DIF
city: Acapulco
country: Mexico
facility: Centro de Investigación Clínica del Pacífico, S.A de C.V.
city: Guadalajara
country: Mexico
facility: Hospital Maria Auxiliadora
city: Mexico City
country: Mexico
facility: Médica Sur
city: Mexico City
country: Mexico
facility: Consultorio Medico
city: Monterrey
country: Mexico
facility: Accelerium S de RL de C.V.
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE - Hospital de São João
city: Porto
country: Portugal
facility: Centro Hospitalar de São João
city: Vila Real
country: Portugal
facility: Centro Hospita de Tras-os-Montes e Alto Douro, EPE
city: Rio Grande
country: Puerto Rico
facility: Caparra Internal Medicine Research Center
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group, LLC
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: San Juan
country: Puerto Rico
facility: Fundación de Investigación
city: Bucharest
country: Romania
facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Timisoara
country: Romania
facility: SC Cabinet Particular Policlinic Algomed SRL
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
city: Moscow
country: Russian Federation
facility: FSBRI "Federal Research Center of nutrition and biotechnology
city: Moscow
country: Russian Federation
facility: I. M. Sechenov - First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: M. F. Vladimirsky - Clinical Research Institution of Moscow Region
city: Saint Petersburg
country: Russian Federation
facility: Military medical academy n. a. S.M. Kirov
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital No. 31
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
city: Cape Town
country: South Africa
facility: Mediclinic Constantiaberg
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma (Pty) Ltd
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Bern
country: Switzerland
facility: INSELSPITAL, University Hospital Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi
city: Fatih
country: Turkey
facility: Bezmiâlem Vakıf Üniversitesi
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
city: Izmir
country: Turkey
facility: Ege Üniversitesi
city: Pendik
country: Turkey
facility: Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
city: Çapa
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS foundation Trust
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
city: London
country: United Kingdom
facility: Bart Health NHS Trust- Royal London Hospital
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust - St George's Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust - Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Study officials:
affiliation: Genfit
name: Carol Addy, MD MMSc
role: STUDY_DIRECTOR
References: