Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Liver Fibrosis Due to NASH
In brief
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)
Key facts
- Study ID
- NCT01672866
- Run by
- Gilead Sciences
- People needed
- 222
- Starts
- 2012-12-05
- Expected to finish
- 2016-12-29
- Last updated by the study team
- 2019-03-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 — St 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
- Mayo Clinic Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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