drugset / Trial / NCT05900050
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
RandomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2023-07-02
- Primary completion
- 2025-10-15
- Completion
- 2025-10-15
Outcome
Outcome not reported
Stopped (Business): “Sponsor Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VS-01 | Other / unclassified | — | Other |