Clinical Trial Details

Trial ID: L0347
Source ID: NCT01672866
Associated Drug: Simtuzumab
Title: Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT01672866/results
Conditions: Liver Fibrosis Due to NASH
Interventions: Biological: Placebo|Biological: SIM
Outcome Measures: Change From Baseline in MQC on Liver Biopsy|Event Free Survival (EFS) Using Kaplan-Meier
Sponsor/Collaborators: Gilead Sciences
Gender: All
Age: 18 Years to 65 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 222
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: December 5, 2012
Completion Date: December 29, 2016
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019
Locations: Mayo Clinic Hospital, Phoenix, Arizona, United States|Southern California Liver Centers, Coronado, California, United States|University of California, San Diego (UCSD), San Diego, California, United States|University of California San Francisco (UCSF), San Francisco, California, United States|University of Colorado, Aurora, Colorado, United States|Miami Veterans Administration Healthcare System, Miami, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Northwestern University, Chicago, Illinois, United States|Indianapolis Gastroenterology Research Foundation, Indianapolis, Indiana, United States|Iowa Digestive Disease Center, Clive, Iowa, United States|University of Louisville, Louisville, Kentucky, United States|Tulane University, New Orleans, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic, Burlington, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Minnnesota Gastroenterology, PA, Saint Paul, Minnesota, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Saint Louis University Hospital, Saint Louis, Missouri, United States|State University Of New York, Buffalo, New York, United States|Weill Cornell Medical College, New York, New York, United States|Mount Sinai Hospital, New York, New York, United States|Duke University, Durham, North Carolina, United States|University Hospitals Case Medical Center, Cleveland, Ohio, United States|Cleveland Clinic, Cleveland, Ohio, United States|University of Pennsylvania, Philadelphia, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|St. Luke's Episcopal Hospital, Houston, Texas, United States|Alamo Clinical Research Associates, San Antonio, Texas, United States|University of Utah, Salt Lake City, Utah, United States|University of Virginia Health System, Charlottesville, Virginia, United States|Liver Institute of Virginia, Newport News, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Bucheon St. Marys Hospital, Richmond, Virginia, United States|Virginia Commonwealth University Health System, Richmond, Virginia, United States|Virginia Mason Medical Center, Seattle, Washington, United States|University of Washington, Seattle, Washington, United States|H??pital Erasme, Brussels, Belgium|Universit?? Catholique de Louvain, Bruxelles, Belgium|UZ Ghent, Gent, Belgium|University of Calgary, Calgary, Alberta, Canada|University of Manitoba, Winnipeg, Manitoba, Canada|London Health Science Center, London, Ontario, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|Hopital Beaujon, Clichy, France|Hospital Saint-Antoine, Paris, France|Groupe Hospitalier Piti??- Salp??tri??re, Paris, France|CHU Strasbourg H??pital Civil, Strasbourg, France|Medizinische Hochschule Hannover, Hannover, Germany|Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel, Germany|EUGASTRO GmbH, Leipzig, Germany|Azienda Ospedaliero-Universitaria di Modena Policlinico, Modena, Italy|Azienda Ospedaliera San Camillo Forlanini, Roma, Italy|Azienda Ospedaliera Citt?? della Salute e della Scienza di Torino, Torino, Italy|Fundacion De Investigacion, San Juan, Puerto Rico|Hospital Vall d'Hebron, Barcelona, Spain|Hospital Clinic de Barcelona, Barcelona, Spain|Hospital Universitario Puerta de Hierro, Majadahonda, Spain|Hospital Donostia, San Sebastian, Spain|John Radcliffe Hospital, Headington, United Kingdom|The Royal London Hospital, London, United Kingdom|Royal Free Hospital, Pond Street, London, United Kingdom|King's College Hospital NHS Foundation Trust No. 1 Account, London, United Kingdom|Nottingham University Hospitals Queens Medica, Nottingham, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT01672866

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D337 Simtuzumab Biological drug DB12152 LOXL2; antibody Anti-fibrosis; Anticancer agent; Immunomodulator; Failed in clinical trials Details