TerminatedNCT05900050Updated Jul 23, 2026Results posted

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

A Phase 2 interventional study of VS-01 on top of SOC and SOC (Control Group) in Acute-On-Chronic Liver Failure and Ascites, sponsored by Genfit. Terminated at 26 sites in 7 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Genfit · Phase 2, Interventional, and Treatment

Why this study was terminated

Sponsor Decision

Phase: Phase 2
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 18 Years to 79 Years
Sex: All

Study 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 studied

Acute-On-Chronic Liver Failure
Ascites

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Keywords

Chronic liver diseases
Hepatic Dysfunction
Extrahepatic Organ Dysfunction
Liver Failure
Renal Disease
Hepatic Impairment
Renal Impairment
Hepatic Decompensation
Cirrhosis

In context

Acute-On-Chronic Liver Failure

169 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 57 are open to participants now.

This study's enrollment of 15 is below the median of 73 across 99 interventional studies indexed under Acute-On-Chronic Liver Failure.

Browse Acute-On-Chronic Liver Failure studies →

Lead sponsor

Genfit is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
VS-01 on top of SOC (Active Treatment Group)
Patients randomized to Active Treatment group will receive VS-01 on top of SOC
Drug: VS-01 on top of SOC
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
Other: SOC (Control Group)

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: Day 7

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 28
Number of Participants With ≥ 1 ACLF Grade Regression
ACLF regression was defined as regression of at least one full grade.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 90

Results

Posted Jul 23, 2026

Limitations and caveats

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.

Participant flow

A total of 15 participants were enrolled into this trial in the United States, Germany and France between July 2023 and October 2025.

Participant flow — Overall Study
Milestone	Active Treatment Group: VS-01 on Top of Standard of Care (SOC)	Control Group: SOC Alone
Started	9	6
Completed	3	2
Not completed	6	4
Withdrew: Death	4	2
Withdrew: Liver transplant	2	0
Withdrew: Withdrawal of consent	0	1
Withdrew: Lost to follow-up	0	1

Outcome measures

PrimaryChronic 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.

Time frame:: Day 7
Reported as:: Mean · score on a scale

Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
score on a scale	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7	50.852 ± 15.5459	39.866 ± 6.3557

SecondaryNumber of Deaths From Day 1 to Day 90

90-Day mortality was reported as the number of deaths from Day 1 to Day 90.

Time frame:: Day 1 to Day 90
Reported as:: Count of participants · Participants

Number of Deaths From Day 1 to Day 90
Participants	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Number of Deaths From Day 1 to Day 90	4	1

SecondaryNumber of Deaths From Day 1 to Day 28

28-Day mortality was reported as the number of deaths from Day 1 to Day 28.

Time frame:: Day 1 to Day 28
Reported as:: Count of participants · Participants

Number of Deaths From Day 1 to Day 28
Participants	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Number of Deaths From Day 1 to Day 28	4	0

SecondaryTime 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.

Time frame:: Day 1 to Day 90
Reported as:: Median · days

Time to Death Through Day 90
days	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Time to Death Through Day 90	NA (18 to —)	NA

SecondaryNumber of Participants With ACLF Resolution

ACLF resolution was defined as ACLF grade 'No ACLF', for participants who had ACLF at Baseline.

Time frame:: Baseline to Day 7 and Day 28
Reported as:: Count of participants · Participants

Number of Participants With ACLF Resolution
Participants	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Day 7 — Resolution	1	1
Day 7 — No Resolution	2	2
Day 28 — Resolution	1	2
Day 28 — No Resolution	2	1

SecondaryTime 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.

Time frame:: Baseline to Day 28
Reported as:: Median · days

Time to ACLF Resolution Through Day 28
days	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Time to ACLF Resolution Through Day 28	NA (3 to —)	13 (5 to —)

SecondaryNumber of Participants With ≥ 1 ACLF Grade Regression

ACLF regression was defined as regression of at least one full grade.

Time frame:: Baseline, Day 7 and Day 28
Reported as:: Count of participants · Participants

Number of Participants With ≥ 1 ACLF Grade Regression
Participants	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Day 7 — Regression	1	1
Day 7 — No Regression	8	5
Day 28 — Regression	1	2
Day 28 — No Regression	8	4

SecondaryTime 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.

Time frame:: Baseline and Day 28
Reported as:: Median · days

Time to ≥ 1 ACLF Grade Regression Through Day 28
days	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Time to ≥ 1 ACLF Grade Regression Through Day 28	NA	NA (13 to —)

SecondarySecondary: 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.

Time frame:: Day 1 through Day 90
Reported as:: Median · days

Secondary: Time to Transplant or Death Through Day 90
days	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Death	22 (18 to —)	NA

SecondaryNumber 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.

Time frame:: Up to Day 90
Reported as:: Count of participants · Participants

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Any TEAEs	9	6
Any Grade 3 or Higher TEAEs	8	5
Any TEAEs Related to VS-01	6	NA
Any Serious TEAEs	7	5
Any Serious TEAEs Related to VS-01	2	NA

Adverse events

Collected over Up to Day 90. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Active Treatment Group: VS-01 on Top of SOC	4/9 (44.4%)	7/9 (77.8%)	9/9 (100%)
Control Group: SOC Alone	2/6 (33.3%)	5/6 (83.3%)	6/6 (100%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
Hepatic encephalopathyNervous system disorders	2/9	0/6
Chronic hepatic failureHepatobiliary disorders	1/9	1/6
Hepatic cirrhosisHepatobiliary disorders	1/9	1/6
PneumoniaInfections and infestations	0/9	1/6
Disturbance in attentionNervous system disorders	0/9	1/6
Gastrointestinal haemorrhageGastrointestinal disorders	1/9	1/6
Pleural effusionRespiratory, thoracic and mediastinal disorders	0/9	1/6
HyponatraemiaMetabolism and nutrition disorders	0/9	1/6
Mental status changesPsychiatric disorders	0/9	1/6
Acute on chronic liver failureHepatobiliary disorders	1/9	0/6

Most frequent other events

Showing 10 of 71

Most frequent other events
Event	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone
HypocalcaemiaMetabolism and nutrition disorders	3/9	0/6
HypokalaemiaMetabolism and nutrition disorders	1/9	2/6
DiarrhoeaGastrointestinal disorders	2/9	2/6
AnaemiaBlood and lymphatic system disorders	1/9	2/6
HyperkalaemiaMetabolism and nutrition disorders	2/9	0/6
HypomagnesaemiaMetabolism and nutrition disorders	2/9	0/6
PneumoniaInfections and infestations	2/9	1/6
EncephalopathyNervous system disorders	2/9	0/6
SyncopeNervous system disorders	2/9	0/6
Acute kidney injuryRenal and urinary disorders	2/9	0/6

Baseline characteristics

Full Analysis Set (FAS): All randomized participants.

Age, Continuous
Age, Continuous(years)	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone	Total
Mean	56.59 ± 8.210	51.18 ± 11.295	54.43 ± 9.571

Sex: Female, Male
Sex: Female, Male(Participants)	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone	Total
Female	0	3	3
Male	9	3	12

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	6	5	11
More than one race	0	0	0
Unknown or Not Reported	2	0	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Active Treatment Group: VS-01 on Top of SOC	Control Group: SOC Alone	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	6	6	12
Unknown or Not Reported	2	0	2

Study locations

26 sites

University of California Davis Medical Center
Sacramento, California 95817, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia 20007, United States
Tampa General Hospital
Tampa, Florida 33606, United States
Piedmont Atlanta Hospital
Atlanta, Georgia 30309, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
University of Missouri Health Care
Columbia, Missouri 65212, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York 10032, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
The Liver Institute at Methodist Dallas
Dallas, Texas 75203, United States
Baylor Clinic
Houston, Texas 77030, United States
Richmond VA Medical Center
Richmond, Virginia 23249, United States
Virginia Commonwealth University
Richmond, Virginia 23298, United States
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Centre Hospitalier Régional Universitaire de Tours
Chambray-lès-Tours, 37170, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Hôpital Universitaire Pitié Salpêtrière
Paris, 75013, France
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Universitatsklinikum Munster
Münster, North Rhine-Westphalia 48149, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin 13353, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
Eger, 3300, Hungary
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, 00185, Italy
Hospital Clínic de Barcelona
Barcelona, Barcelona 08036, Spain

References and documents

Study documents

Study protocol · Jan 27, 2025
Statistical analysis plan · Aug 27, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05900050
Lead sponsor: Genfit
Responsible party: Sponsor
First posted: Jun 12, 2023
Start date: Jul 2, 2023
Primary completion: Oct 15, 2025
Completion: Oct 15, 2025
Results posted: Jul 23, 2026
Last update: Jul 23, 2026

Study contacts

Pejvack MOTLAGH, M.D, M.Sc

study director · Genfit

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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