Clinical Trial Details

Trial ID: L0343
Source ID: NCT02686762
Associated Drug: Emricasan
Title: Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
Acronym: ENCORE-NF
Status: Completed
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis|Fibrosis|Liver Diseases
Interventions: Drug: Emricasan (5 mg)|Drug: Emricasan (50 mg)|Drug: Placebo
Outcome Measures: Fibrosis improvement by at least one stage without worsening of steatohepatitis|Steatohepatitis resolution (based on liver biopsy)|Improvement in the Non-alcoholic fatty liver disease (NAFLD) Activity Score|Caspase 3/7 Relative Light Units and Alanine aminotransferase (ALT)
Sponsor/Collaborators: Conatus Pharmaceuticals Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 318
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: January 26, 2016
Completion Date: February 28, 2019
Results First Posted: --
Last Update Posted: August 19, 2019
Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|University of Arizona Clinical and Translational Sciences Research Center, Tucson, Arizona, United States|Preferred Research Partners, Inc., Little Rock, Arkansas, United States|Fresno Clinical Research Center, Freestone, California, United States|UCLA The Pfleger Liver Institute, Los Angeles, California, United States|Gastrointestinal Biosciences, Los Angeles, California, United States|Surinder Singh Saini, M.D., Inc., Newport Beach, California, United States|California Liver Research Institute, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|University of California Davis Medical Center, Sacramento, California, United States|University of California San Diego Medical Center, San Diego, California, United States|Cedars Sinai Medical Center, West Hollywood, California, United States|Yale University School of Medicine, New Haven, Connecticut, United States|Sibley Memorial Hospital, Washington, District of Columbia, United States|Howard University, Washington, District of Columbia, United States|UF Hepatology Research at CTRB, Gainesville, Florida, United States|Florida Digestive Health Specialist, Lakewood Ranch, Florida, United States|Miami Veterans Administration Healthcare System, Miami, Florida, United States|University of Miami/Schiff Center for Liver Diseases, Miami, Florida, United States|Florida Hospital Orlando Transplant Institute, Orlando, Florida, United States|Tampa General Medical Group, Tampa, Florida, United States|iResearch Atlanta LLC, Decatur, Georgia, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, United States|Northwestern Memorial Hospital, Chicago, Illinois, United States|Rush University Medical Center, Chicago, Illinois, United States|The University of Chicago Medical Center, Chicago, Illinois, United States|Aquiant Research, New Albany, Indiana, United States|Iowa Digestive Disease Center, P.C, Clive, Iowa, United States|UnityPoint Clinic Center For Liver Disease, Des Moines, Iowa, United States|University of Louisville, Louisville, Kentucky, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, United States|Louisiana Research Center, LLC, Shreveport, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic Medical Center, Burlington, Massachusetts, United States|Henry Ford Health System, Detroit, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|Kansas City VA Medical Center, Kansas City, Missouri, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Washington University School of Medicine-Infectious Disease Clinical Research Unit, Saint Louis, Missouri, United States|Doctors Office Center, Newark, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|State University of New York, Buffalo, New York, United States|Northwell Health, Inc., Manhasset, New York, United States|Mount Sinai Beth Israel Medical Center, New York, New York, United States|NYU Langone Medical Center, New York, New York, United States|Columbia University Medical Center (CUMC), New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|Asheville Gastroenterology Associates, PA, Asheville, North Carolina, United States|Carolinas Healthcare System, Center for Liver Disease, Charlotte, North Carolina, United States|Duke University Medical Center, Duke South Clinics, Durham, North Carolina, United States|Rex Healthcare, Raleigh, North Carolina, United States|Consultants for Clinical Research, Cincinnati, Ohio, United States|University Hospitals Case Medical Center, Cleveland, Ohio, United States|Options Health Research, LLC, Tulsa, Oklahoma, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Temple University Hospital, Philadelphia, Pennsylvania, United States|Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|PMG Research at Charleston, Charleston, South Carolina, United States|ClinSearch, LLC, Chattanooga, Tennessee, United States|Gastro One, Germantown, Tennessee, United States|Methodist University Hospital, Memphis, Tennessee, United States|Vanderbilt University Medical Center - Digestive Disease Center, Nashville, Tennessee, United States|Texas Clinical Research Institute, Arlington, Texas, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|Baylor All Saints Medical Center, Fort Worth, Texas, United States|Baylor College of Medicine, Houston, Texas, United States|Liver Associates of Texas, P.A., Houston, Texas, United States|Research Specialists of Texas, Houston, Texas, United States|Pinnacle Clinical Research, PLLC, Live Oak, Texas, United States|American Research Corporation at the Texas Liver Institue, San Antonio, Texas, United States|Brooke Army Medical Center, San Antonio, Texas, United States|University of Utah Health Sciences Center, Salt Lake City, Utah, United States|University of Vermont, Burlington, Vermont, United States|Bon Secours Richmond Health System, Newport News, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|McGuire VA Medical Center, Richmond, Virginia, United States|University of Washington Harborview Medical Center, Seattle, Washington, United States|Universit??tsklinikum der RWTH Aachen, Aachen, North Rhine-Westphalia, Germany|Universit??tsklinikum Bonn, Bonning, North Rhine-Westphalia, Germany|Universit??tsklinikum M??nster, Munster, North Rhine-Westphalia, Germany|Charit?? - Universit??tsmedizin Berlin, Berlin, Germany|Universit??tsklinikum Freiburg, Freiburg, Germany|Universit??tsklinikum Hamburg Eppendorf, Hamburg, Germany|Medizinische Hochschule Hannover, Hannover, Germany|Eugastro GmbH, Leipzig, Germany|Universit??tsmedizin der Johannes Gutenberg-Universit??t Mainz, Mainz, Germany|Hospital Universitario Vall d'Hebron, Barcelona, Spain|Hospital Clinic de Barcelona, Barcelona, Spain|Hospital Universitario de La Princesa, Madrid, Spain|Hospital General Universitario Gregorio Mara??on, Madrid, Spain|Hospital Universitario Ramon y Cajal, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Spain|Hospital Universitario de Donostia, San Sebastian, Spain|Hospital Universitario Marques de Valdecilla, Santander, Spain|Hospital Clinico Universitario de Valencia, Valencia, Spain|Hospital General Universitario de Valencia, Valencia, Spain
URL: https://ClinicalTrials.gov/show/NCT02686762