Clinical Trial Details

Trial ID: L0334
Source ID: NCT03439254
Associated Drug: Obeticholic Acid
Title: Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Acronym: REVERSE
Status: Active, not recruiting
Study Results: No Results Available
Results: --
Conditions: Compensated Cirrhosis|Nonalcoholic Steatohepatitis
Interventions: Drug: Obeticholic acid (10 mg)|Drug: Obeticholic acid (10 mg to 25 mg)|Drug: Placebo
Outcome Measures: Percentage of subjects with improvement in fibrosis by at least 1 stage with no worsening of NASH, using NASH Clinical Research Network (CRN) scoring system|Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria|Percentage of subjects with NASH resolution, using the NASH CRN scoring
Sponsor/Collaborators: Intercept Pharmaceuticals
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 919
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: August 30, 2017
Completion Date: August 2022
Results First Posted: --
Last Update Posted: March 9, 2022
Locations: University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States|Digestive Health Specialists of the Southeast, Dothan, Alabama, United States|Objective GI d/b/a North Alabama GI Research Center, Madison, Alabama, United States|Arizona Liver Health, Chandler, Arizona, United States|Arizona Liver Health, Glendale, Arizona, United States|The Institute for Liver Health, Tucson, Arizona, United States|Liver Wellness Center, Little Rock, Arkansas, United States|Arkansas Gastroenterology, North Little Rock, Arkansas, United States|Hope Clinical Research, Canoga Park, California, United States|Precision Research Institute, Chula Vista, California, United States|University of California, San Francisco-Fresno, Fresno, California, United States|Scripps Whittier Diabetes Institute, La Jolla, California, United States|eStudySite, La Mesa, California, United States|Keck Hospital of USC, Los Angeles, California, United States|Cedars-Sinani Medical Center, Los Angeles, California, United States|Palmtree Clinical Research, INC., Palm Springs, California, United States|Stanford University Medical Center, Palo Alto, 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|Kaiser Permanente Sacramento Medical Center, Sacramento, California, United States|University of California, San Francisco, San Francisco, California, United States|University of Colorado Denver and Hospital, Aurora, Colorado, United States|Peak Gastroenterology Associates, Colorado Springs, Colorado, United States|South Denver Gastroenterology, PC, Englewood, Colorado, United States|Innovative Medical Research of South Florida, Inc., Aventura, Florida, United States|Medycal Research, Inc., Brooksville, Florida, United States|Hi Tech and Global Research LLC, Coral Gables, Florida, United States|Top Medical Research, Inc., Cutler Bay, Florida, United States|Integrity Clinical Research, LLC, Doral, Florida, United States|Nature Coast Clinical Research, Inverness, Florida, United States|UF Health Jacksonville-Gastroenterology Emerson, Jacksonville, Florida, United States|Mayo Clinic Florida, Jacksonville, Florida, United States|Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States|Sensible Healthcare, LLC, Ocoee, Florida, United States|Innovation Medical Research Center, Palmetto Bay, Florida, United States|Gastroenterology Associates of Pensacola, PA, Pensacola, Florida, United States|Tampa General Medical Group, Tampa, Florida, United States|Guardian Angel Research Center, INC, Tampa, Florida, United States|Florida Medical Clinic, P.A, Zephyrhills, Florida, United States|Summit Clinical Research, LLC, Athens, Georgia, United States|The Emory Clinic (TEC), Atlanta, Georgia, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, United States|Grand Teton Research Group, PLLC, Idaho Falls, Idaho, United States|Rush University Medical Center, Chicago, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|Aquiant Research, New Albany, Indiana, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Kansas Medical Clinic, Topeka, Kansas, United States|University of Louisville, Clinical Trials Unit, Louisville, Kentucky, United States|Tandem Clinical Research, LLC, Marrero, Louisiana, United States|Delta Research Partners, LLC, Monroe, Louisiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Louisiana Research Center, 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|Lahey Hospital & Medical Center, Burlington, Massachusetts, United States|UMass Memorial Health Care, Worcester, Massachusetts, United States|Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center, Wyoming, Michigan, United States|Huron Gastroenterology Associates, Ypsilanti, Michigan, United States|Minnesota Gastroenterology, P.A., Saint Paul, Minnesota, United States|Southern Therapy and Advanced Research (STAR) LLC, Jackson, Mississippi, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|CHI Health Alegent Creighton Clinic, Omaha, Nebraska, United States|Sierra Clinical Research, Las Vegas, Nevada, United States|Amici GI-LLC, Martinsville, New Jersey, United States|Rutgers New Jersey Medical School, Newark, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|University at Buffalo, Clinical and Translational Research Center, Buffalo, New York, United States|Ichan School of Medicine at Mount Sinai Beth Israel, New York, New York, United States|NYU Langone Health, New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|Ichan School of Medicine at Mount Sinai, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|Asheville Gastroenterology Associates, P.A., Asheville, North Carolina, United States|University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill, North Carolina, United States|Charlotte Gastroenterology & Hepatology, PLLC, Charlotte, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States|Carolinas Center for Liver Disease/Carolinas HealthCare System, Huntersville, North Carolina, United States|Carolinas Health Care System Center for Liver Disease, Huntersville, North Carolina, United States|Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, United States|PMG Research of Rocky Mount, LLC, Rocky Mount, North Carolina, United States|Trial Management Associates, LLC, Wilmington, North Carolina, United States|Dayton Gastroenterology, Inc., Beavercreek, Ohio, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, United States|Northeast Clinical Research Center, LLC, Bethlehem, Pennsylvania, United States|The Pennsylvania State University and the Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Einstein Healthcare Network, Philadelphia, Pennsylvania, United States|UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute, Pittsburgh, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, United States|SCTR Research Nexus, Charleston, South Carolina, United States|Rapid City Medical Center LLP, Rapid City, South Dakota, United States|Gastro One, Germantown, Tennessee, United States|Associates in Gastroenterology, PLC, Hermitage, Tennessee, United States|Johnson City Medical Center, Johnson City, Tennessee, United States|Associates in Gastroenterology, PLC, Lebanon, Tennessee, United States|Methodist Healthcare University Hospital, Memphis, Tennessee, United States|Quaility Medical Research, PLLC, Nashville, Tennessee, United States|Vanderbilt University Medical Center - Digestive Disease Center, Nashville, Tennessee, United States|Texas Clinical Research Institute LLC, Arlington, Texas, United States|The Liver Institute at Methodist Dallas Medical Center, Dallas, Texas, United States|Liver Center of Texas, Dallas, Texas, United States|Texas Digestive Disease Consultants, Dallas, Texas, United States|UT Southwestern Medical Center, Dallas, Texas, United States|San Antonio Military Medical Center, Fort Sam Houston, Texas, United States|Baylor Scott and White All Saints Medical Center, Fort Worth, Texas, United States|Texas Digestive Disease Consultants, Fort Worth, Texas, United States|Baylor College of Medicine - Advanced Liver Therapies, Houston, Texas, United States|Baylor College of Medicine - Ben Taub Hospital, Houston, Texas, United States|The University of Texas Medical School at Houston, Houston, Texas, United States|Centex Studies, Inc., Houston, Texas, United States|Centex Studies, Inc., McAllen, Texas, United States|American Research Corporation, San Antonio, Texas, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States|Texas Digestive Disease Consultants, San Marcos, Texas, United States|The University of Vermont Medical Center, Burlington, Vermont, United States|Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads, Newport News, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours, Richmond, Virginia, United States|McGuire VA Medical Center, Richmond, Virginia, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Gastroenterology Consultants of Southwest Virginia, Roanoke, Virginia, United States|Virginia Mason - Seattle Medical Center, Seattle, Washington, United States|Harborview Medical Center, Seattle, Washington, United States|University of Washington Medical Center, Seattle, Washington, United States|Nepean Blue Mountains Local Health District, Nepean Hospital, Kingswood, New South Wales, Australia|Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia|Mater Misericordiae Limited, South Brisbane, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Flinders Medical Centre, Bedford Park, South Australia, Australia|St Vincent's Hospital, Fitzroy, Victoria, Australia|Austin Health, Heidelberg, Victoria, Australia|Royal Melbourne Hospital, Parkville, Victoria, Australia|Fiona Stanley Hospital, Murdoch, Western Australia, Australia|University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary, Alberta, Canada|Gordon and Leslie Diamond Helath Care Centre, Vancouver, British Columbia, Canada|(G.I.R.I.) GI Research Institute, Vancouver, British Columbia, Canada|Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada|Kent Place, Lindsay, Ontario, Canada|London Health Sciences Centre-University Hospital, London, Ontario, Canada|Office of Dr. Gauthier, North Bay, Ontario, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|Chronic Viral Illness/McGill University Health Centre (MUHC), Montreal, Quebec, Canada|Clinique de medecine Urbaine du Quartier Latin, Montr??al, Quebec, Canada|CHU Amiens Picardie, Amiens, France|Centre Hospitalier Universitaire d'Angers, Angers, France|H??pital Beaujon- Service d'Hepatologie, Clichy, France|Center Hospitalier Universitaire Grenoble Alpes, La Tronche, France|H??pital de la Croix Rousse, Lyon Cedex 04, France|CHU de Nice, H??pital de l'Archet 2, Nice, France|H??pital Piti??-Salp??trier??, Paris, France|CHU de Rouen-Centre Hospitalier Universitaire, Rouen, France|Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France|H??pital Hautepierre, Strasbourg, France|H??pital Purpan, Toulouse, France|CHRU de Nancy - H??pitaux de Brabois, Vandoeuvre-les-Nancy, France|H??pital Paul Brousse, Villejuif, France|Univerit??tsklinkum W??rzburg, W??rzburg, Bayern, Germany|Teuber Consulting & Research UG, Frankfurt am main, Hessen, Germany|Universit??tsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany|EUGASTRO GmbH, Leipzig, Sachsen, Germany|Universit??tsklinikum Leipzig A??R, Leipzig, Sachsen, Germany|Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel, Schleswig-Holstein, Germany|Charit?? - Universit??tsmedzin Berlin, Berlin, Germany|Universit??tsklinikum Hamburg Eppendorf, Hamburg, Germany|Synexus Magyarorsz??g Kft. Budapest, Budapest, Hungary|Synexus Magyarorszag Kft. Debrecen A.S., Debrecen, Hungary|Synexus Magyarorszag Kft. Gyula DRS, Gyula, Hungary|Middlemore Hospital, Auckland, New Zealand|Christchurch Hospital, Christchurch, New Zealand|Dunedin Public Hospital, Dunedin, New Zealand|Wellington Regional Hospital, Wellington, New Zealand|Synexus Polska Sp. z o.o., Oddzia?? w Cz??stochowie, Cz??stochowa, Poland|Synexus Polska Sp. z.o.o., Oddzia?? w Gda??sku, Gda??sk, Poland|Synexus Polska Sp. Z.o.o., Oddzia?? w Gdyni, Gdynia, Poland|Synexus Polska Sp. z o.o., Oddzia?? w Katowicach, Katowice, Poland|Synexus Polska Sp. z o.o., Oddzia?? w Poznaniu, Pozna??, Poland|Synexus Polska Sp. z o.o., Oddzia?? w Warszawie, Warszawa, Poland|Synexus Polska Sp. z o.o., Oddzia?? w Wroc??awiu, Wroc??aw, Poland|Synexus Polska Sp. z o.o., Oddzia?? w ??odzi, ????d??, Poland|Latin Clinical Trial Center, San Juan, Puerto Rico|Fundaci??n de Investigaci??n de Diego, San Juan, Puerto Rico|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Cl??nic de Barcelona, Barcelona, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Universitario Virgen del Rocio, Sevilla, Spain|Hospital Clinico Universitario de Valencia, Valencia, Spain|Hospital General Universitario de Valencia, Valencia, Spain|Hospital Universitari i Polit??cnic La Fe, Valencia, Spain|Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department, Kyiv, Ukraine|Kyiv Railway Clinical Hospital ???2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department, Kyiv, Ukraine|Derby Teaching Hospitals NHS Foundation Trust, Derby, Derbyshire, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, United Kingdom|Addenbrooke's Hospital, Cambridge, England, United Kingdom|Royal Free Hospital NHS Foundation Trust, London, England, United Kingdom|King's College Hospital NHS Foundation Trust, London, England, United Kingdom|Imperial College Healthcare NHS Trust, St Mary's Hospital, London, England, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, England, United Kingdom|Derriford Hospital, Plymouth, England, United Kingdom|Belfast Health and Social Care Trust, Belfast, Northern Ireland, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom|The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle Upon Tyne, Tyne And Wear, United Kingdom|Abertawe Bro Morganinwg University Local Health Board, Swansea, Wales, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03439254