NCT03053050

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 808 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	SEL	Tablets administered orally once daily
DRUG	Placebo to match SEL 6 mg	Tablets administered orally once daily
DRUG	Placebo to match SEL 18 mg	Tablets administered orally once daily

Timeline

• Start date: 2017-02-13
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2017-02-14
• Last updated: 2020-06-29
• Results posted: 2020-06-29

Locations

298 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study