Acute-On-Chronic Liver FailurePhase 2NCT05900050

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

A Phase 2 study testing VS-01 on top of SOC in people with Acute-On-Chronic Liver Failure and Ascites, run by Genfit at 26 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Acute-On-Chronic Liver Failure, Ascites
What is being tested?: VS-01 on top of SOC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 26 sitesin 7 countries
Study dates: 2 Jul 2023to 15 Oct 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 20Show fewer

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.

Trial locations and contacts

26 sites in 7 countries.

Country

City, postcode or hospital

26 sites in 7 countries

United States13 sites

Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri Health Care
Columbia, Missouri, 65212
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Baylor Clinic
Houston, Texas, 77030
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
Richmond VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis Medical Center
Sacramento, California, 95817
Tampa General Hospital
Tampa, Florida, 33606
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

France4 sites

Centre Hospitalier Régional Universitaire de Tours
Chambray-lès-Tours, 37170
Hôpital de la Croix Rousse
Lyon, 69004
Hôpital Universitaire Pitié Salpêtrière
Paris, 75013
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033

Other trials in France

Germany3 sites

Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Medizinische Hochschule Hannover
Hanover, 30625
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Hungary2 sites

Debreceni Egyetem Klinikai Központ
Debrecen, 4032
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
Eger, 3300

Other trials in Hungary

Italy2 sites

ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, 00185

Other trials in Italy

Belgium1 site

Universitair Ziekenhuis Antwerpen
Edegem, 2650

Other trials in Belgium

Spain1 site

Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: 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)

Conditions: Acute-On-Chronic Liver Failure, Ascites
Being tested: VS-01 on top of SOC, SOC (Control Group)
Keywords: Chronic liver diseases, Hepatic Dysfunction, Extrahepatic Organ Dysfunction, Liver Failure, Renal Disease, Hepatic Impairment, Renal Impairment, Hepatic Decompensation, Cirrhosis
Medical subject headings: Acute-On-Chronic Liver Failure, Ascites, Liver Diseases, Liver Failure, Kidney Diseases, Renal Insufficiency, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VS-01 on top of SOCDrug
Patients will receive VS-01 intraperitoneally on four consecutive days on top of SOC
SOC (Control Group)Other
Patients will receive SOC for decompensated cirrhosis and ACLF

Study groups in NCT05900050
Study group	Role	What they receive
VS-01 on top of SOC (Active Treatment Group)	Experimental	Patients randomized to Active Treatment group will receive VS-01 on top of SOC Receives: 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 Receives: Other: SOC (Control Group)

What is being measured

The primary outcome is the main question the study is designed to answer.

Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
The CLIF-C ACLF score is derived from the CLIF-C organ failure (OF) score. The formula for the CLIF-C ACLF score is CLIF-ACLF = 10*[0.33*CLIF-C OF + 0.04*Age + 0.63*Ln(white cell count) -2]. The CLIF-C ACLF score ranges from 0-100, where a higher score indicated a greater mortality risk.
Measured: Day 7

Secondary outcomes (9)

Number of Deaths From Day 1 to Day 90
90-Day mortality was reported as the number of deaths from Day 1 to Day 90.
Measured: Day 1 to Day 90
Number of Deaths From Day 1 to Day 28
28-Day mortality was reported as the number of deaths from Day 1 to Day 28.
Measured: Day 1 to Day 28
Time to Death Through Day 90
Time to death was calculated as death date - treatment start date. Participants who were not observed to have encountered the event through Day 90 were censored.
The inter-quartile range was obtained via Kaplan Meier estimation.
Measured: Day 1 to Day 90
Number of Participants With ACLF Resolution
ACLF resolution was defined as ACLF grade 'No ACLF', for participants who had ACLF at Baseline.
Measured: Baseline to Day 7 and Day 28
Time to ACLF Resolution Through Day 28
ACLF resolution was defined as ACLF grade 'No ACLF', for participants who had ACLF at Baseline. Time to ACLF resolution was calculated as (ACLF resolution date - treatment start date). Participants who were not observed to have encountered the event through Day 28 were censored at min[trial discontinuation date; Day 28 visit date or treatment start date +27 if no visit date; last contact/assessment date for participant lost to follow-up; date of liver transplant or transjugular intrahepatic portosystemic shunt (TIPS)].
The inter-quartile range was obtained via Kaplan Meier estimation.
Measured: Baseline to Day 28
Number of Participants With ≥ 1 ACLF Grade Regression
ACLF regression was defined as regression of at least one full grade.
Measured: Baseline, Day 7 and Day 28
Time to ≥ 1 ACLF Grade Regression Through Day 28
Time to ACLF ≥ 1 grade regression was calculated as (ACLF ≥ 1 grade regression date - treatment start date). Participants who were not observed to have encountered the event through Day 28 were censored.
The inter-quartile range was obtained via Kaplan Meier estimation.
Measured: Baseline and Day 28
Secondary: Time to Transplant or Death Through Day 90
Time to transplant was calculated as (transplant or death date - treatment start date). Participants who were not observed to have encountered the event through Day 90 were censored.
The inter-quartile range was obtained via Kaplan Meier estimation.
Measured: Day 1 through Day 90
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a study drug and that does not necessarily have a causal relationship with this treatment. A TEAE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after at least one dose of the study drug had been administered, even if the event was not considered to be related to the study drug. A serious AE (SAE) was any untoward medical event that occurs at any dose that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or was an important medical event.
Measured: Up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 202315 Oct 2025

First posted12 Jun 2023
Study start2 Jul 2023
Primary completion15 Oct 2025
Study completion15 Oct 2025

Why it stopped: Sponsor Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05900050
Sponsor's protocol ID: VS01-IIa-01
Other IDs: 2024-513706-56-00
Status last verified: Jun 2026
First submitted: 2 Jun 2023
Last updated: 23 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Very Low-volume Plasma Exchange in ACLF
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Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
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All Acute-On-Chronic Liver Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05900050
Acronym / sponsor ID: VS01-IIa-01
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
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor Decision
Enrolment: 15 participants (actual)
Lead sponsor: GenfitIndustry (pharma, biotech, devices)
Study start: 2 Jul 2023 (actual)
Primary completion: 15 Oct 2025 (actual)
Study completion: 15 Oct 2025 (actual)
First posted: 12 Jun 2023 (actual)
Results: Posted 23 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VS-01 on top of SOC (Active Treatment Group)	Experimental	Drug: VS-01 on top of SOCPatients randomized to Active Treatment group will receive VS-01 on top of SOC
SOC (Control Group)	Other	Other: SOC (Control Group)Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (20 listed)

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:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VS-01 on top of SOCPatients will receive VS-01 intraperitoneally on four consecutive days on top of SOC	Drug	VS-01 on top of SOC (Active Treatment Group)
SOC (Control Group)Patients will receive SOC for decompensated cirrhosis and ACLF	Other	SOC (Control Group)

Primary outcome

Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
Time frame: Day 7
The CLIF-C ACLF score is derived from the CLIF-C organ failure (OF) score. The formula for the CLIF-C ACLF score is CLIF-ACLF = 10*[0.33*CLIF-C OF + 0.04*Age + 0.63*Ln(white cell count) -2]. The CLIF-C ACLF score ranges from 0-100, where a higher score indicated a greater mortality risk.

9 secondary outcomes

Number of Deaths From Day 1 to Day 90
Time frame: Day 1 to Day 90
Number of Deaths From Day 1 to Day 28
Time frame: Day 1 to Day 28
Time to Death Through Day 90
Time frame: Day 1 to Day 90
Number of Participants With ACLF Resolution
Time frame: Baseline to Day 7 and Day 28
Time to ACLF Resolution Through Day 28
Time frame: Baseline to Day 28
Number of Participants With ≥ 1 ACLF Grade Regression
Time frame: Baseline, Day 7 and Day 28
Time to ≥ 1 ACLF Grade Regression Through Day 28
Time frame: Baseline and Day 28
Secondary: Time to Transplant or Death Through Day 90
Time frame: Day 1 through Day 90
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 90

Results and safety

Results posted to the registry on 23 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment Group: VS-01 on Top of Standard of Care (SOC)	9	3
Control Group: SOC Alone	6	2

Primary outcome: Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7

Time frame: Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Treatment Group: VS-01 on Top of SOC n = 5	Control Group: SOC Alone n = 2
Value	50.852 (15.5459)	39.866 (6.3557)

Population analysed: FAS: All randomized participants. Only participants with available data were included in this analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 90. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment Group: VS-01 on Top of SOC	7 of 9 (77.8%)	9 of 9 (100%)	4 of 9
Control Group: SOC Alone	5 of 6 (83.3%)	6 of 6 (100%)	2 of 6

Limitations and caveats (from the sponsor): Due to premature discontinuation of the trial and the limited sample size, all analyses were descriptive. No inferential statistical testing was performed, and no formal conclusions can be drawn.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute-On-Chronic Liver Failure

Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
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Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pejvack MOTLAGH, M.D, M.Sc study director

Genfit

26 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VS-01 on top of SOC in people with Acute-On-Chronic Liver Failure and Ascites, run by Genfit at 26 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, France, Germany, Hungary, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.