clinical trial · NCT05900050
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
Genfit·phase2·terminated·n = 15
Acute-On-Chronic Liver FailureAscitesVS-01 on top of SOCSOC (Control Group)
brief summary
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)
started
Jul 2, 2023
primary completion
Oct 15, 2025
completion
Oct 15, 2025
last updated
Jan 14, 2026
official title
A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol