This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Ocaliva
  • /
  • Randomized Global Phase 3 Study to Evaluate the Im...
Clinical trial

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

Read time: 2 mins
Last updated:31st Aug 2015
Identifier: NCT02548351

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.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 2370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date: September 2015
Estimated Primary Completion Date: October 2022
Estimated Study Completion Date: October 2022

- Experimental:
10 mg Obeticholic Acid
- Experimental: 25 mg Obeticholic Acid
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-01-31
Study type(s) Interventional
Expected enrolment 2370
Study start date 2015-09-01
Estimated primary completion date 2022-10-01

View full details