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.
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 a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with NASH/MASH cirrhosis and fibrosis stage 4.
To evaluate the safety and tolerability of
denifanstat 50 mg compared to placebo in patients
with MASLD/MASH after 52 weeks of treatment.
To evaluate the effect of denifanstat 50 mg compared to placebo in reducing the risk of liver-related composite clinical outcome.
To evaluate the effect of denifanstat 50 mg compared to placebo after 52 weeks of treatment on achieving:
- MASH resolution without worsening of fibrosis,
OR
- Fibrosis regression without worsening of steatohepatitis.
This is a randomized, single-blind controlled, two group, multicenter trial
preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) –
Acute Kidney Injury (HRS-AKI) to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients.
Evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint
The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.
This is a multi-center, randomized, controlled, open-label, Phase 2a
proof of concept study of VS-01 in adult patients with ACLF grades 1
and 2 and ascites. Approximately 60 patients will be enrolled. Sample
size was calculated to meet the study objectives assuming a 10% dropout rate.
The main goal of this study is to evaluate how well taking oral elafibranor 80 mg daily works, compared to a placebo, in reducing or preventing the occurrence of death, liver transplant, worsening of liver disease, and liver disease-related complications in adults with PBC.