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

Stopped early · Phase 2

Conditions studied: Acute-On-Chronic Liver Failure, Ascites

In brief

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)

Key facts

Study ID

NCT05900050

Run by

Genfit

People needed

15

Starts

2023-07-02

Expected to finish

2025-10-15

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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;
• Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);
• Alfapump® in place to manage ascites;
• Pregnancy and lactation;
• Women of child-bearing potential who are not willing to use adequate contraception;
• Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.