NCT05900050

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute-On-Chronic Liver Failure
• Ascites

Interventions

Type	Name	Description
DRUG	VS-01 on top of SOC	Patients will receive VS-01 intraperitoneally on four consecutive days on top of SOC
OTHER	SOC (Control Group)	Patients will receive SOC for decompensated cirrhosis and ACLF

Timeline

• Start date: 2023-07-02
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2023-06-12
• Last updated: 2026-01-14

Locations

26 sites across 7 countries: United States, Belgium, France, Germany, Hungary, Italy, Spain

Regulatory

• FDA-regulated drug study