drugset / Trial / NCT05900050

Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®

NCT05900050 ↗

Phase 2 Terminated 15 enrolled Genfit
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

EvaluationDrugModalityDoseRoute
Subject VS-01 Other / unclassified — Other

Indications