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

NCT ID: NCT05900050

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-02
• Study Completion Date: 2025-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

VS-01 on top of SOC

Intervention Type: DRUG

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

SOC (Control Group)

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

Group Type: OTHER

SOC (Control Group)

Intervention Type: OTHER

Patients will receive SOC for decompensated cirrhosis and ACLF

Interventions

VS-01 on top of SOC

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

Intervention Type: DRUG

SOC (Control Group)

Patients will receive SOC for decompensated cirrhosis and ACLF

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;

2. Onset of ACLF not more than 14 days before Baseline (BL);

3. Presence of ascites requiring diagnostic or therapeutic paracentesis;

4. Patients with dry body weight ≥40 and <140 kg;

5. Written informed consent obtained prior to the start of any study-related procedures.

Exclusion Criteria

1. 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:

1. Respiratory failure necessitating invasive mechanical ventilation;

2. Coagulation failure (INR > 3.2 or platelet count ≤20 x 109/L);

3. Severe cardiovascular failure requiring the use of high dose vasopressors;

2. ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria;

3. Presence of spontaneous or secondary bacterial peritonitis;

4. Presence of uncontrolled severe infection(with hemodynamic instability or shock);

5. Poorly controlled seizure disorder;

6. 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;

7. Contraindication for paracentesis;

8. Coagulation disorders such as disseminated intravascular coagulation or hemophilia;

9. Potential or known hypersensitivity to liposomes;

10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;

11. Patients after organ transplantation receiving immunosuppressive medication;

12. 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;

13. Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);

14. Alfapump® in place to manage ascites;

15. Pregnancy and lactation;

16. Women of child-bearing potential who are not willing to use adequate contraception;

17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genfit

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pejvack MOTLAGH, M.D, M.Sc

Role: STUDY_DIRECTOR

Genfit

Locations

University of California Davis Medical Center

Sacramento, California, United States

Medstar Georgetown University Hospital

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

Tampa General Hospital

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

The Liver Institute at Methodist Dallas

Dallas, Texas, United States

Baylor Clinic

Houston, Texas, United States

Richmond VA Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Centre Hospitalier Régional Universitaire de Tours

Chambray-lès-Tours, , France

Hôpital de la Croix Rousse

Lyon, , France

Hôpital Universitaire Pitié Salpêtrière

Paris, , France

CHU Rennes - Hôpital Pontchaillou

Rennes, , France

Universitatsklinikum Munster

Münster, North Rhine-Westphalia, Germany

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet

Eger, , Hungary

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, , Italy

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Countries

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

Other Identifiers

2024-513706-56-00

Identifier Type: CTIS

Identifier Source: secondary_id

VS01-IIa-01

Identifier Type: -

Identifier Source: org_study_id