Primary objective is to evaluate the effect of EFX compared to placebo on achieving
NASH/MASH resolution AND fibrosis regression at Week 52 (in
Cohort 1 only) and to evaluate the effect of EFX compared to placebo on all-cause
mortality and liver-related clinical outcomes as measured by the
time to first occurrence of any of the predefined, adjudicated events
in subjects with NASH/MASH and fibrosis.
This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.
To evaluate the efficacy of two different dwell times (3 hours and 4 hours) of i.p. VS-01, administered once daily for up to 4 days on top of SOC compared to SOC alone in treating OHE in patients with AD of liver
cirrhosis or ACLF grade 1 measured by time to improvement of OHE.