Clinical Trial Details

Trial ID: L0367
Source ID: NCT01672879
Associated Drug: Simtuzumab
Title: Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
Acronym: NASH
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT01672879/results
Conditions: Liver Fibrosis Due to NASH
Interventions: Biological: Placebo|Biological: SIM
Outcome Measures: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)|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: 259
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: October 29, 2012
Completion Date: January 3, 2017
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, Denver, Aurora, Colorado, United States|University of Miami, Miami, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Northwestern University, Chicago, Illinois, United States|Indiana University School of Medicine, Division of Gastroenterology/Hepatology, 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|Lahey Clinic, Burlington, Massachusetts, United States|University of Mississippi Medical Center, Jackson, Michigan, United States|Minnnesota Gastroenterology, PA, Saint Paul, Minnesota, United States|Saint Louis University Hospital, Saint Louis, Missouri, United States|State University Of New York at Buffalo, Buffalo, New York, United States|North Shore University Health System, Manhasset, New York, United States|New York University, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|University Hospitals Case Medical Center, Cleveland, Ohio, United States|University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Methodist University Hospital, Memphis, Tennessee, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Texas Clinical Research Institute, Arlington, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|St. Luke Episcopal Hospital, Houston, Texas, United States|Alamo Clinical Research Associates, San Antonio, Texas, United States|Intermountain Transplant Center, Murray, Utah, United States|University of Virginia Health Center, 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, Richmond, Virginia, United States|Virginia Mason Medical Center, Seattle, Washington, United States|University of Washington, Seattle, Washington, United States|University of Manitoba, Winnipeg, Manitoba, Canada|Dalhousie University, Halifax, Nova Scotia, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|H??pital de la Croix Rousse, Lyon, France|Hospital Saint-Antoine, Paris, France|CHU Piti??-Salp??tri??re, Paris, France|Fonds de Recherche Honoraires, Strasbourg, France|Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel, Germany|Eugastro Gmbh, Leipzig, Germany|Istituto Clinico Humanitas, Rozzano, Milano, Italy|Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, 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, Cataluna, Spain|Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain|Royal Free Hospital, Pond Street, London, United Kingdom|King's College Hospital NHS Trust, London, United Kingdom|Nottingham University Hospitals Queen's Medical Centre, Nottingham, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT01672879