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Experimental liver drug shows early promise but trial cut short

NCT ID NCT05900050

Disease control Sponsor: Genfit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This early study tested a drug called VS-01 in 15 adults with acute-on-chronic liver failure (a sudden worsening of liver function) and fluid buildup in the belly. Participants received either VS-01 plus standard care or standard care alone. The trial was terminated early, so we have limited data on whether VS-01 helps improve survival or liver function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VS-01 (a liposomal drug given into the abdominal cavity)
What this could lead to
If successful, VS-01 could offer a new way to manage acute-on-chronic liver failure and reduce short-term mortality.
What could go wrong
This is a very early, small study (15 people) that was terminated, so results are limited. The drug is experimental and may not improve outcomes or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure Ascites Fibrosis kidney disorder kidney failure liver disorder liver failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute-on-chronic liver failure Ascites

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Roma, 00185, Italy

  • Baylor Clinic

    Houston, Texas, 77030, United States

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Régional Universitaire de Tours

    Chambray-lès-Tours, 37170, France

  • Charité Universitätsmedizin Berlin

    Berlin, State of Berlin, 13353, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032, Hungary

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet

    Eger, 3300, Hungary

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, 75013, France

  • Hôpital de la Croix Rousse

    Lyon, 69004, France

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medstar Georgetown University Hospital

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

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309, United States

  • Richmond VA Medical Center

    Richmond, Virginia, 23249, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Liver Institute at Methodist Dallas

    Dallas, Texas, 75203, United States

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitatsklinikum Munster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65212, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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