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
Phase of Trial: Phase III
Latest Information Update: 03 Jul 2018
At a glance
- Drugs Obeticholic acid (Primary)
- Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
- Focus Registrational; Therapeutic Use
- Acronyms REGENERATE
- Sponsors Intercept Pharmaceuticals
- 22 Nov 2017 Planned End Date changed from 1 Oct 2021 to 1 Oct 2022.
- 22 Nov 2017 Planned primary completion date changed from 1 Oct 2021 to 1 Oct 2022.
- 01 Nov 2017 According to an Intercept Pharmaceuticals media release, the interim analysis is on track to report in the first half of 2019.