Date trial registered
01.09.2015
Incorporation of the first participant
01.09.2015
Recruitment status
Active, not recruiting
Academic title (Source of data: WHO)
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
Type of trial (Source of data: WHO)
Interventional
Design of the trial (Source of data: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase (Source of data: WHO)
Phase 3
Primary end point (Source of data: WHO)
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with stage 2 or 3 fibrosis by assessing the following primary endpoints;To evaluate the effect of Obeticholic Acid compared to placebo on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint)
Secundary end point (Source of data: WHO)
To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function;To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
Contact information (Source of data: WHO)
Please refer to primary and secondary sponsors