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

NCT05900050 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-14

No results posted yet for this study

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

OTHER

SOC (Control Group)

Patients will receive SOC for decompensated cirrhosis and ACLF

DRUG

VS-01 on top of SOC

Patients will receive VS-01 intraperitoneally on four consecutive days on top of SOC

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pejvack MOTLAGH, M.D, M.Sc · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-02
Primary Completion
2025-10-15
Completion
2025-10-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900050 on ClinicalTrials.gov