Clinical Trial Details

Trial ID: L0157
Source ID: NCT04378010
Associated Drug: EDP-305
Title: A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-Alcoholic Steatohepatitis
Interventions: Drug: EDP-305 1.5 mg|Drug: EDP-305 2 mg|Drug: Placebo
Outcome Measures: Proportion of subjects who achieve ???1 stage improvement in fibrosis without worsening of steatohepatitis and/or resolution of steatohepatitis and no worsening of liver fibrosis as determined by liver biopsy|Safety as assessed by adverse events
Sponsor/Collaborators: Enanta Pharmaceuticals
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 336
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: January 27, 2020
Completion Date: December 2022
Results First Posted: --
Last Update Posted: June 11, 2021
Locations: Arizona Liver Health, Chandler, Arizona, United States|The Institute of Liver Health, Glendale, Arizona, United States|Dignity Health DBA St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States|Del Sol Research Management LLC, Tucson, Arizona, United States|Rajeev Krishan, MD, Inc, Bakersfield, California, United States|Hope Clinical Research, LLC, Canoga Park, California, United States|eStudy Site, Chula Vista, California, United States|Southern California Research Center, Coronado, California, United States|St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton, California, United States|National Institute of Clinical Research, Inc, Garden Grove, California, United States|ADVA Clinical Research, Inglewood, California, United States|eStudySite - La Mesa, La Mesa, California, United States|Om Research LLC, Lancaster, California, United States|Keck Medical Center Of USC, Los Angeles, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|UC Davis Medical Center, Sacramento, California, United States|Southern California Gastrointestinal and Liver Centers, San Clemente, California, United States|Southern California Gastronintestinal and Liver Centers, San Clemente, California, United States|Precision Research Institute, Llc, San Diego, California, United States|Paradigm Clinical Research Institute, Torrance, California, United States|Universal Axon Clinical Research, Doral, Florida, United States|Westside Center for Clinical Research, Fleming Island, Florida, United States|Universal Axon- Homestead, LLC, Homestead, Florida, United States|Nature Coast Clinical Research, Inverness, Florida, United States|Westside Center for Clinical Research, Jacksonville, Florida, United States|Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic, Jacksonville, Florida, United States|Encore Borland Groover Clinical Research, Jacksonville, Florida, United States|Meridien Research, Lakeland, Florida, United States|Meridien Research, Maitland, Florida, United States|San Marcus Research Clinic, Inc., Miami Lakes, Florida, United States|Veritas Research Corp, Miami, Florida, United States|Research Associates of South Florida, Miami, Florida, United States|University of Miami, Miller School of Medicine-Don Soffer Clinical Research Center, Miami, Florida, United States|Well Pharma Medical Research, Corp., Miami, Florida, United States|Med Research Of Florida, LLC, Miami, Florida, United States|Ocala GI Research, Ocala, Florida, United States|IMIC, Inc., Palmetto Bay, Florida, United States|Meridien Research, Saint Petersburg, Florida, United States|Guardian Angel Research, Tampa, Florida, United States|Agile Clinical Research Trials, LLC, Atlanta, Georgia, United States|Northwestern University, Chicago, Illinois, United States|Rush University Medical Center - University Cardiovascular Surgeons, Chicago, Illinois, United States|Digestive Research Alliance of Michiana, South Bend, Indiana, United States|University Of Iowa Hospital & Clinics, Iowa City, Iowa, United States|Ochsner Health System, New Orleans, Louisiana, United States|University of Maryland, Baltimore, Maryland, United States|Mercy Medical Center, Baltimore, Maryland, United States|Digestive Disease Associates, PA, Catonsville, Maryland, United States|Mid-Atlantic GI Research, Greenbelt, Maryland, United States|Henry Ford Health Hospital, Detroit, Michigan, United States|Southern Therapy and Advanced Research LLC GI Associates and Endoscopy Center, Jackson, Mississippi, United States|St. Louis Univ. School Of Medicine, Saint Louis, Missouri, United States|AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey, United States|Intercity Gastroenterology, Fresh Meadows, New York, United States|New York University Medical Centre, New York, New York, United States|University of Rochester Medical Center School of Medicine and Dentistry, Rochester, New York, United States|Northeast GI Research Division, Concord, North Carolina, United States|Carolinas HealthCare System Digestive - Huntersville, Huntersville, North Carolina, United States|Lucas Research, Morehead City, North Carolina, United States|Cleveland Clinic - Taussig Cancer Institute, Cleveland, Ohio, United States|University of Pittsburgh Medical Center - Center for Liver Diseases, Pittsburgh, Pennsylvania, United States|Digestive Health Research, LLC, Hermitage, Tennessee, United States|Digestive Health Research, Lebanon, Tennessee, United States|Quality Medical Research, Nashville, Tennessee, United States|Texas Clinical Research Institute, Arlington, Texas, United States|Texas Diabetes & Endocrinology, Austin, Texas, United States|Crescent Health Clinical, DeSoto, Texas, United States|DHAT Research Institute, Garland, Texas, United States|American Research Corporation at the Texas Liver Institute, Houston, Texas, United States|American Research Corporation at The Texas Liver Institute, San Antonio, Texas, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States|Bon Secours St. Mary's Hospital of Richmond, Inc, Newport News, Virginia, United States|Liver Institute Northwest, Seattle, Washington, United States|CINME, Buenos Aires, Caba, Argentina|University of Calgary, Calgary, Alberta, Canada|Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, Frankfurt am Main, Hessen, Germany|Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR, Mainz, Rheinland-Pfalz, Germany|Latin Clinical Trial Center, San Juan, Puerto Rico|MediNova West London Quality Research Site, Wokingham, Berkshire, United Kingdom|MeDiNova East London Quality Research Site, Romford, Essex, United Kingdom|King's College Hospital - King's College Hospital NHS Foundation Trust, London, Greater London, United Kingdom|MeDiNova South London Quality Research Site, Sidcup, Kent, United Kingdom|MeDiNova Northampton Dedicated research site, Corby, Northamptonshire, United Kingdom|MeDiNova Warwickshire Quality Research Site, Kenilworth, Warwickshire, United Kingdom|MeDiNova Yorkshire Quality Research Site, Shipley, Yorkshire, United Kingdom|MeDiNova North London Quality Research Site, Middlesex, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT04378010