Last updated on February 2019

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


Brief description of study

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.

Clinical Study Identifier: NCT02704403

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University of Alabama at Birmingham
Birmingham, AL United States
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The Institute for Liver Health
Chandler, AZ United States
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Dignity Health St. Joseph's Hospital
Phoenix, AZ United States
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The University of Arizona College of Medicine Liver Research Institute
Tucson, AZ United States
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GW Research, Inc.
Chula Vista, CA United States
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Southern California Research Center
Coronado, CA United States
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University of California, San Francisco, Fresno Community Regional Medical Center
Fresno, CA United States
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Scripps Clinic Torrey Pines
La Jolla, CA United States
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VA Long Beach Healthcare System
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Cedars Sinai Medical Center
Los Angeles, CA United States
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Alliance Clinical Research
Oceanside, CA United States
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Alliance Clinical Research
Poway, CA United States
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Medical Associates Research Group, Inc.
San Diego, CA United States
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VA San Diego HealthCare System
San Diego, CA United States
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Quest Clinical Research
San Francisco, CA United States
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Sutter West Bay Hospitals dba California Pacific Medical Center
San Francisco, CA United States
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University of California, San Francisco, Medical Center at Parnassus
San Francisco, CA United States
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Ventura Clinical Trials
Ventura, CA United States
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South Denver Gastroenterology
Englewood, CO United States
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Yale University SCHOOL OF MEDICINE, SECTION OF DIGESTIVE DISEASES
New Haven, CT United States
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University of Florida
Gainesville, FL United States
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Mayo Clinic Hospital
Jacksonville, FL United States
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Atlantic Gastroenterology Associates, LLC
Lakewood Ranch, FL United States
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University of Miami - Miller School of Medicine
Miami, FL United States
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University of Miami - Schiff Center for Liver Diseases
Miami, FL United States
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Emory University Hospital Midtown
Atlanta, GA United States
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Piedmont Atlanta Hospital
Atlanta, GA United States
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Atlanta Medical Center, Inc.
Atlanta, GA United States
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Honolulu, HI United States
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Northwestern Memorial Hospital - Arkes Family Pavilion
Chicago, IL United States
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University of Chicago
Chicago, IL United States
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Loyola University Chicago
Maywood, IL United States
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Gastroenterology Associates of Hazard
Hazard, KY United States
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University of Kentucky Chandler Medical Center
Lexington, KY United States
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University of Louisville Medical / Dental Complex
Louisville, KY United States
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Tulane University School of Medicine
New Orleans, LA United States
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Louisiana Research Center, LLC
Shreveport, LA United States
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Baltimore, MD United States
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Rockville, MD United States
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Tufts Medical Center
Boston, MA United States
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Massachusetts General Hospital
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Beth Israel Deaconess Medical Center (BIDMC)
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University of Massachusetts Memorial Medical Center
Worcester, MA United States
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Henry Ford Health System, Division of Gastroenterology & Hepatology
Detroit, MI United States
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Gastrointestinal Associates & Endoscopy Center
Flowood, MS United States
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University of Mississippi Medical Center
Jackson, MS United States
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St. Luke's Liver Transplant & Specialist
Kansas City, MO United States
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Kansas City Research Institute
Kansas City, MO United States
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Saint Louis University School of Medicine
Saint Louis, MO United States
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Amici Clinical Research LLC
Martinsville, NJ United States
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Rutgers, Robert Wood Johnson Medical School
New Brunswick, NJ United States
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Rutgers, New Jersey Medical School
Newark, NJ United States
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Hofstra Northwell School of Medicine
Manhasset, NY United States
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Concorde Medical Group
New York, NY United States
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Weill Medical College of Cornell University
New York, NY United States
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Icahn School of Medicine at Mount Sinai
New York, NY United States
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New York-Presbyterian Hospital - Columbia University Medical Center
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Beth Israel Medical Center
New York, NY United States
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Premier Medical Group
Poughkeepsie, NY United States
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Asheville Gastroenterology Associates
Asheville, NC United States
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UNC Health Care System
Chapel Hill, NC United States
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Carolinas Medical Center
Charlotte, NC United States
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Duke Gastroenterology
Durham, NC United States
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Cumberland Research Associates, LLC
Fayetteville, NC United States
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Wake Research Associates
Raleigh, NC United States
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Piedmont Healthcare
Statesville, NC United States
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Trial Management Associates
Wilmington, NC United States
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Ohio Gastroenterology & Liver Institute
Cincinnati, OH United States
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University of Cincinnati Physicians Company , LLC
Cincinnati, OH United States
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Cleveland, OH United States
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Tulsa, OK United States
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Philadelphia, PA United States
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Charleston, SC United States
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Charleston, SC United States
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Associates in Gastroenterology, PLC
Hermitage, TN United States
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Memphis, TN United States
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Nashville, TN United States
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Arlington, TX United States
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Houston, TX United States
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Centex Studies Inc.
Houston, TX United States
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Houston, TX United States
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Live Oak, TX United States
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Rollingwood, TX United States
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San Antonio, TX United States
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Texas Digestive Consultants (TDDC)
Southlake, TX United States
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Victoria Gastroenterology
Victoria, TX United States
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University of Utah School of Medicine
Salt Lake City, UT United States
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University of Virginia
Charlottesville, VA United States
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Inova Fairfax Medical Campus - Center for Liver Disease
Falls Church, VA United States
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Bon Secours Liver Institute of Virginia - Newport News
Newport News, VA United States
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Bon Secours Liver Institute of Virginia - Richmond
Richmond, VA United States
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Virginia Commonwealth University
Richmond, VA United States
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Springfield, VA United States
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Harborview Medical Center
Seattle, WA United States
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Swedish Organ Transplant and Liver Center
Seattle, WA United States
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Hospital Alem n
Buenos Aires, Argentina
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Centro De Hepatologia Ciudad de La Plata
La Plata, Argentina
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Pilar, Argentina
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Bedford Park, Australia
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Cliniques Universitaires Saint-Luc
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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Instituto do F gado e Transplantes de Pernambuco
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Salvador, Brazil
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Sao Jose do Rio Preto, Brazil
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Abbottsford, Canada
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Vancouver, BC, Canada
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Vina Del Mar, Chile
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Plzen, Czechia
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Praha 2, Czechia
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Aarhus, Denmark
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Helsinki, Finland
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Amiens, France
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Angers, France
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Clamart, France
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Vandoeuvre Les Nancy, France
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Aachen, Germany
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Berlin, Germany
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Gastroenterologie am Bayerischen Platz/ Gastro-Studien
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
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San Giovanni Rotondo, Italy
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Torino, Italy
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Acapulco, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Amsterdam, Netherlands
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Coimbra, Portugal
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Lisboa, Portugal
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Porto, Portugal
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Centro Hospitalar de S o Jo o
Porto, Portugal
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Caparra Internal Medicine Research Center
Rio Grande, Puerto Rico
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Klinical Investigations Group, LLC
San Juan, Puerto Rico
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San Juan, Puerto Rico
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Bucharest, Romania
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Bucharest, Romania
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Timisoara, Romania
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Timisoara, Romania
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Moscow, Russian Federation
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Moscow, Russian Federation
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Moscow, Russian Federation
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Military medical academy n. a. S.M. Kirov
Saint Petersburg, Russian Federation
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City Clinical Hospital No. 31
St. Petersburg, Russian Federation
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Tiervlei Trial Centre
Cape Town, South Africa
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Mediclinic Constantiaberg
Cape Town, South Africa
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Phoenix Pharma (Pty) Ltd
Port Elizabeth, South Africa
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Majadahonda, Spain
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Pontevedra, Spain
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Santander, Spain
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Sevilla, Spain
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Stockholm, Sweden
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Bern, Switzerland
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Lausanne, Switzerland
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Zurich, Switzerland
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Fatih Istanbul, Turkey
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Izmir, Turkey
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Pendik Istanbul, Turkey
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Umraniye /Istanbul, Turkey
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Frimley, United Kingdom
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Guildford, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Portsmouth, United Kingdom
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The Institute for Liver Health
Glendale, AZ United States
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Keck Hospital of USC
Los Angeles, CA United States
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Ruane Clinical Research Group Inc.
Los Angeles, CA United States
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Gastrointestinal Biosciences Clinical Trials LLC
Los Angeles, CA United States
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Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
Los Angeles, CA United States
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Georgetown University Hospitals
Washington, WA United States
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Sibley Memorial Hospital
Washington, WA United States
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Integrity Clinical Research LLC
Doral, FL United States
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Nature Coast Clinical Research
Inverness, FL United States
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South Florida Center of Gastroenterology, PA
Wellington, FL United States
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Florida Medical Clinic, PA
Zephyrhills, FL United States
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Montefiore Medical Center
Bronx, NY United States
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Liver Center of Texas
Dallas, TX United States
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GENFIT

Gulf Coast Research Group LLC
Houston, TX United States
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GENFIT

Centex Studies Inc
McAllen, TX United States
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GENFIT

EUGASTRO GmbH
Leipzig, Germany
  Connect »

GENFIT

St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N 31
Saint Petersburg, Russian Federation
  Connect »

GENFIT

Mayo Clinic Hospital
Phoenix, AZ United States
  Connect »

GENFIT

Instituto de Investigaciones Clinicas San Nicolas SRL
San Nicolas, Argentina
  Connect »

GENFIT

Instituto Medico Alas
Salta, Argentina
  Connect »

GENFIT

Kantonsspital St. Gallen
Saint Gallen, Switzerland
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GENFIT

The Ohio State University Wexner Medical Center
Columbus, OH United States
  Connect »

GENFIT

Axismed S.R.L
Caba, Argentina
  Connect »

GENFIT

Centro Hospita de Tras-os-Montes e Alto Douro, EPE
Vila Real, Portugal
  Connect »

GENFIT

Universit tsklinikum Magdeburg
Magdeburg, Germany
  Connect »

GENFIT

Banner University Medical Center Phoenix
Phoenix, AZ United States
  Connect »

GENFIT

Adobe Clinical Research, LLC
Tucson, AZ United States
  Connect »

GENFIT

Kansas City VA Medical Center
Kansas City, MO United States
  Connect »

GENFIT

University at Buffalo, Clinical and Translational Research Center
Buffalo, NY United States
  Connect »

GENFIT

New York University Langone Medical Center
New York, NY United States
  Connect »

GENFIT

Sanatorio G emes
Caba, Argentina
  Connect »

GENFIT

University of California, Davis Medical Center
Sacramento, CA United States
  Connect »

GENFIT

Solano&Terront Servicios M dicos LTDA - Unidad Integral de Endocrinologia UNIENDO
Bogota D.C, Colombia
  Connect »

GENFIT

Loma Linda University Medical Center - Transplantation Insitute
Loma Linda, CA United States
  Connect »

GENFIT

Dim Clinica Privada
Ramos Mejía, Argentina
  Connect »

GENFIT

Hospital das Cl nicas da Faculdade de Medicina de Ribeir o Preto da Universidade de S o Paulo
Ribeirão Preto, Brazil
  Connect »

GENFIT

Hospital S rio-Liban s
São Paulo, Brazil
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GENFIT

Universidade Federal de S o Paulo - UNIFESP
São Paulo, Brazil
  Connect »

GENFIT

Faculdade de Medicina da Universidade de S o Paulo
São Paulo, Brazil
  Connect »

GENFIT

Alta Salud
Los Ángeles, Chile
  Connect »

GENFIT

Fundaci n Cardio Infantil - Instituto de Cardiolog a
Bogotá, Colombia
  Connect »

GENFIT

Fundaci n Santa Fe de Bogot Centro de Estudios e Investigaci n en Salud (CEIS)
Bogotá, Colombia
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GENFIT

Fundacion Hospitalaria San Vicente de Paul
Medellín, Colombia
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GENFIT

H pital Henri Mondor
Créteil, France
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GENFIT

Universit tsklinikum K ln
Köln, Germany
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GENFIT

Universit tsklinikum W rzburg
Würzburg, Germany
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GENFIT

Hospital Universitario Virgen de la Victoria
Málaga, Spain
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Recruitment Status: Open


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