Trials / Terminated
TerminatedNCT03053063
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 883 (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 associated complications in adults with cirrhosis due to NASH.
Conditions
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
- 2017-01-30
- Primary completion
- 2019-05-06
- Completion
- 2019-05-06
- First posted
- 2017-02-14
- Last updated
- 2020-05-07
- Results posted
- 2020-05-07
Locations
283 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, New Zealand, Poland, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03053063. Inclusion in this directory is not an endorsement.