Trials / Terminated
TerminatedNCT02704403
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,157 (actual)
- Sponsor
- Genfit · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elafibranor | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2020-10-28
- Completion
- 2020-10-28
- First posted
- 2016-03-10
- Last updated
- 2022-03-23
- Results posted
- 2022-03-23
Locations
326 sites across 25 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02704403. Inclusion in this directory is not an endorsement.