Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
| Condition | Acute-On-Chronic Liver Failure, Ascites |
|---|---|
| Phase | Phase 2 |
| Sponsor | Genfit |
| Status | Terminated |
| Enrollment | 15 participants |
| Interventions | VS-01 on top of SOC, SOC (Control Group) |
| Start date | Jul 2, 2023 |
| Completion date | Oct 15, 2025 |
| Results posted | Jul 23, 2026 |
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)
Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
| Active Treatment Group: VS-01 on Top of SOC | 50.852 ± 15.5459 score on a scale |
|---|---|
| Control Group: SOC Alone | 39.866 ± 6.3557 score on a scale |
Open in BENITIONS View on ClinicalTrials.gov
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