Trials / Terminated
TerminatedNCT02548351
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,477 (actual)
- Sponsor
- Intercept Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obeticholic Acid | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-09-22
- Primary completion
- 2023-09-15
- Completion
- 2023-09-15
- First posted
- 2015-09-14
- Last updated
- 2024-10-01
- Results posted
- 2024-09-05
Locations
346 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Puerto Rico, Serbia, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02548351. Inclusion in this directory is not an endorsement.