Clinical Trial Details

Trial ID: L0213
Source ID: NCT03449446
Associated Drug: Selonsertib
Title: Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Acronym: ATLAS
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03449446/results
Conditions: Nonalcoholic Steatohepatitis
Interventions: Drug: SEL|Drug: FIR|Drug: CILO|Drug: Placebo to match FIR|Drug: Placebo to match CILO|Drug: Placebo to match SEL
Outcome Measures: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities|Percentage of Participants Who Achieved a ??? 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Sponsor/Collaborators: Gilead Sciences
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 395
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: March 21, 2018
Completion Date: November 19, 2019
Results First Posted: December 3, 2020
Last Update Posted: December 3, 2020
Locations: The Institute for Liver Health, Chandler, Arizona, United States|Mayo Clinic Arizona, Mayo Clinic Hospital, Phoenix, Arizona, United States|Liver Wellness Center, Little Rock, Arkansas, United States|Arkansas Gastroenterology, North Little Rock, Arkansas, United States|eStudySite, Chula Vista, California, United States|Southern California Liver Center, Coronado, California, United States|Fresno Clinical Research Center, Fresno, California, United States|UCSD NAFLD Clinical Research Center, La Jolla, California, United States|Ruane Clinical Research Group Inc., Los Angeles, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|California Liver Research Institute, Pasadena, California, United States|Huntington Medical Research Institutes Liver Center, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|University of California, Davis Medical Center (study visits), Sacramento, California, United States|Medical Associates Research Group, San Diego, California, United States|South Denver Gastroenterology, PC, Englewood, Colorado, United States|Integrity Clinical Research, Doral, Florida, United States|UF Hepatology Research at CTRB, Gainesville, Florida, United States|Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States|IMIC Inc, Miami, Florida, United States|Genoma Research Group, Miami, Florida, United States|Florida Research Institute, Tampa, Florida, United States|Digestive Healthcare of Georgia, Atlanta, Georgia, United States|Piedmont Hospital, Atlanta, Georgia, United States|Gastrointestinal Diseases Research, Columbus, Georgia, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, United States|Northwestern University; Feinberg School of Medicine, Chicago, Illinois, United States|Indianapolis Gastroenterology Research Foundation, Indianapolis, Indiana, United States|Iowa Digestive Disease Center, P.C., Clive, Iowa, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Delta Research Partners, LLC, Bastrop, Louisiana, United States|Tulane University, New Orleans, Louisiana, United States|Louisiana Research Center, LLC, Shreveport, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Digestive Disease Associates, PA, Catonsville, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Henry Ford Health Systems, Detroit, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|Southern Therapy and Advanced Research (STAR) LLC, Ridgeland, Mississippi, United States|Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States|Saint Louis University, Saint Louis, Missouri, United States|Jubilee Clinical Research, Inc., Las Vegas, Nevada, United States|Rutgers New Jersey Medical School- Doctors Office Center, Newark, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|Sandra Atlas Bass Center for Liver Diseases and Transplantation, Manhasset, New York, United States|Icahn School of Medicine at Mount Sinai Beth Israel, New York, New York, United States|Concorde Medical Group, PLLC, 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|Icahn School of Medicine at Mount Sinai, New York, New York, United States|Carolinas Healthcare System Center for Liver Disease and Transplant, Charlotte, North Carolina, United States|Duke University Medical Center, Duke South Clinics, Durham, North Carolina, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States|Consultants for Clinical Research wed, Cincinnati, Ohio, United States|Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute, Pittsburgh, Pennsylvania, United States|VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Medical University of South Carolina (Liver Biopsy), Charleston, South Carolina, United States|GHS Gastroenterology and Liver Center, Greenville, South Carolina, United States|Gastro One, Germantown, Tennessee, United States|Quality Medical Research, PLLC, Nashville, Tennessee, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Pinnacle Clinical Research, PLLC, Austin, Texas, United States|Austin Center for Clinical Research, Austin, Texas, United States|The Liver Institute at Methodist Dallas Medical Center, Dallas, Texas, United States|University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials, Dallas, Texas, United States|Baylor College of Medicine - Advanced Liver Therapies, Houston, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|Pinnacle Clinical Research, Live Oak, Texas, United States|American Research Corporation at Texas Liver Institute, San Antonio, Texas, United States|Intermountain Liver Disease and Transplant Center, Murray, Utah, United States|University of Utah Hospital, Salt Lake City, Utah, United States|University of Virginia Medical Center, Charlottesville, Virginia, United States|California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant, Falls Church, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond, Richmond, Virginia, United States|McGuire DVAMC, Richmond, Virginia, United States|Virginia Mason Medical Center, Seattle, Washington, United States|Swedish Organ Transplant and Liver Center, Seattle, Washington, United States|Royal Brisbane & Women's Hospital, Herston, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Monash Health, Monash Medical Centre, Clayton, Victoria, Australia|St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia|Melbourne Health, Royal Melbourne Hospital, Parkville, Victoria, Australia|Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia|Royal Perth Hospital, Perth, Western Australia, Australia|Royal Prince Alfred Hospital, Camperdown, Australia|St Vincent's Hospital Sydney, Darlinghurst, Australia|Austin Health, Heidelberg, Australia|The Alfred Hospital, Alfred Health, Melbourne, Australia|Westmead Hospital, Westmead, Australia|William Osler Health System-Brampton Civic Hospital, Brampton, Canada|University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary, Canada|Chronic Viral Illness Service McGill University Health Centre (MUHC)/ Royal Victoria Hospital, Montreal, Canada|Toronto General Hospital, Toronto, Canada|Toronto Liver Centre, Toronto, Canada|Prince of Wales Hospital, Shatin, Hong Kong|Auckland City Hospital, Auckland, New Zealand|Fundacion de Investigacion de Diego, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT03449446