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Evaluating VS-01 for patients with acute-on-chronic liver failure and fluid buildup

A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)

Phase 2 Interventional Genfit · NCT05900050

This study is testing a new treatment called VS-01 for adults with acute-on-chronic liver failure and fluid buildup to see if it helps improve their liver function and overall health compared to standard care alone.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 79 Years
SexAll
SponsorGenfit Industry-sponsored
Locations30 sites (Phoenix, Arizona and 29 other locations)
Trial IDNCT05900050 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial investigates the efficacy, safety, and tolerability of VS-01, a liposomal formulation administered intraperitoneally, in adult patients experiencing acute-on-chronic liver failure (ACLF) with ascites. The study is randomized, controlled, and open-label, comparing the effects of VS-01 alongside standard of care (SOC) against SOC alone. Patients eligible for the trial must have a recent onset of ACLF and require paracentesis for ascites management. The trial aims to assess improvements in liver function and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with ACLF Grade 1, 2, or 3a who have developed ascites within the last 14 days.

Not a fit: Patients with severe organ failures or those classified as ACLF Grade 3b will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver function and quality of life for patients suffering from acute-on-chronic liver failure.

How similar studies have performed: While this approach is novel, similar studies targeting liver dysfunction have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute-On-Chronic Liver FailureAscitesChronic liver diseasesHepatic DysfunctionExtrahepatic Organ DysfunctionLiver FailureRenal DiseaseHepatic Impairment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.