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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Nonalcoholic Steatohepatitis
In brief
The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, without worsening of NASH
Key facts
- Study ID
- NCT03449446
- Run by
- Gilead Sciences
- People needed
- 395
- Starts
- 2018-03-21
- Expected to finish
- 2019-11-19
- Last updated by the study team
- 2020-12-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- The Institute for Liver Health — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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