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

NCT05900050 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: VS01-IIa-012024-513706-56-00
• Study Type: interventional
• Target: 15
• Locations: 7 countries
• Sites: 26

Brief 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

Keywords

Chronic liver diseases; Hepatic Dysfunction; Extrahepatic Organ Dysfunction; Liver Failure; Renal Disease; Hepatic Impairment; Renal Impairment; Hepatic Decompensation; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7

  7 days

Secondary Outcomes (5)

• Time to death through Days 28 and 90

  Day 1 through Days 28 and 90

• Change in ACLF grade through/at Days 7 and 28

  Day 1 through Day 7 and Day 28, at Days 7 and 28

• 28-day and 90-day mortality

  At Days 28 and 90

• Transplant-free survival through/at Days 28 and 90

  Day 1 through Days 28 and 90, at Day 28 and 90

• Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.

  Day 0 to Day 90

Study Arms (2)

VS-01 on top of SOC (Active Treatment Group)

EXPERIMENTAL

Patients randomized to Active Treatment group will receive VS-01 on top of SOC

Drug: VS-01 on top of SOC

SOC (Control Group)

OTHER

Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF

Other: SOC (Control Group)

Interventions

SOC (Control Group) OTHER

Patients will receive SOC for decompensated cirrhosis and ACLF

SOC (Control Group)

VS-01 on top of SOC DRUG

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

VS-01 on top of SOC (Active Treatment Group)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;
• Onset of ACLF not more than 14 days before Baseline (BL);
• Presence of ascites requiring diagnostic or therapeutic paracentesis;
• Patients with dry body weight ≥40 and \<140 kg;
• Written informed consent obtained prior to the start of any study-related procedures.

You may not qualify if:

• Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores:
• Respiratory failure necessitating invasive mechanical ventilation;
• Coagulation failure (INR \> 3.2 or platelet count ≤20 x 109/L);
• Severe cardiovascular failure requiring the use of high dose vasopressors;
• ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria;
• Presence of spontaneous or secondary bacterial peritonitis;
• Presence of uncontrolled severe infection(with hemodynamic instability or shock);
• Poorly controlled seizure disorder;
• Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL;
• Contraindication for paracentesis;
• Coagulation disorders such as disseminated intravascular coagulation or hemophilia;
• Potential or known hypersensitivity to liposomes;
• Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
• Patients after organ transplantation receiving immunosuppressive medication;
• Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs;

Sponsors & Collaborators

• Genfit: lead

Study Sites (26)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

Baylor Clinic

Houston, Texas, 77030, United States

Location

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Centre Hospitalier Régional Universitaire de Tours

Chambray-lès-Tours, 37170, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, 75013, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

Universitatsklinikum Munster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Debreceni Egyetem Klinikai Központ

Debrecen, 4032, Hungary

Location

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet

Eger, 3300, Hungary

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, 00185, Italy

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Ascites; Liver Diseases; Liver Failure; Kidney Diseases; Renal Insufficiency; Fibrosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Hepatic Insufficiency; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pejvack MOTLAGH, M.D, M.Sc

  Genfit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: July 2, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: January 14, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2); IT (2); FR (4); DE (3); ES (1); US (13); BE (1)