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A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy

A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care Versus Standard of Care Alone in Patients With Overt Hepatic Encephalopathy

NCT06987968•Genfit

View on ClinicalTrials.gov

Summary

A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1)Patients with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings and/or histology), who are diagnosed with Overt hepatic encephalopathy (OHE) (according to Hepatic Encephalopathy Grading Instrument) in the presence of:
•1. Acute decompensation (AD)(defined as the onset or worsening of ascites, hepatic encephalopathy, gastrointestinal (GI) bleeding or any combination of them with or without infection); or
•2. Acute on chronic liver failure (ACLF) grade 1 according to European Association for the Study of the Liver(EASL-CLIF) criteria; 2)Presence of ascites requiring diagnostic or therapeutic paracentesis; 3)Fasting blood ammonia \> upper limit of normal (ULN) at baseline (BL); 4)Patients with a dry body weight ≥40 kg and \<140 kg; 5)Male and female patients ≥18 to \<80 years of age on the day of signing the informed consent form (ICF); 6)Patients willing and able to provide written informed consent. If the patient is unable to fully understand or sign the written informed consent based on the Investigator's judgment, the ICF must be signed by a legal representative of the patient according to local regulation.

Exclusion Criteria

•1. ACLF grade 2 or higher as defined by European Association for the Study of the Liver-Chronic Liver Failure-Chronic Liver Failure (EASL-CLIF) criteria;
•2. Presence of spontaneous or secondary bacterial peritonitis (i.e., neutrophil counts \>250/mm3 in ascitic fluid);
•3. Contraindication for paracentesis according to the European Association for the Study of the Liver (EASL) Clinical Practice Guidelines 2018, and American Association for the Study of Liver Diseases (AASLD)Guideline on the Treatment of Ascites, Spontaneous Bacterial Peritonitis, and Hepatorenal Syndrome 2021;
•4. Alfapump® in place to manage ascites;
•5. Known hypersensitivity to liposomes, history of mastocytosis, multiple hypersensitivities or similar diseases known to be associated with an increased risk of allergic/anaphylactoid reactions;
•6. Upper GI bleeding within the last 7 days prior to BL, acute bleeding or bleeding upon paracentesis at Screening (SCR) or Baseline (BL);
•7. Poorly controlled seizure disorder;
•8. Respiratory failure requiring invasive mechanical ventilation;
•9. Severe circulatory failure requiring the use of high dose vasopressors (e.g., dopamine \>15 μg/kg/min, or epinephrine \>0.1 μg/kg/min, or norepinephrine \>0.1 μg/kg/min); the use of terlipressin or low-dose norepinephrine to treat hepatorenal syndrome is not an exclusion criterion;
•10. Uncontrolled severe infection with hemodynamic instability or shock; patients may be enrolled provided anti-infectives have been administered for at least 48 hours prior to BL with an appropriate response as assessed by the Principal Investigator (PI);
+6 more criteria

Locations (6)

96 Jonathan Lucas St, CSB (Main Hospital), Suite 908

Charleston, South Carolina, United States

Nouvel Hôpital Civil, Service de Medecine Intensive Reanimation, 1, place de l'Hôpital

Strasbourg, France

Georgian Clinics" Kutaisi Referral Hospital 2, Otskheli str.

Kutaisi, Georgia

LEPL The First University Clinic of Tbilisi State, Medical University, Gudamakari str.4,,LEPL The First University Clinic

Tbilisi, Georgia

LLC Geo Hospitals Tbilisi, Multiprofile Medical Center, Tsinandali ,str. 9/3

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva, High Medical Technology University Clinic, Tsinandali Street

Tbilisi, Georgia

Key Dates

Start Date

August 25, 2025

Primary Completion Date

September 8, 2025

Completion Date

September 15, 2025

Last Updated

January 12, 2026

Enrollment

ACTUAL participants

Conditions

Hepatic EncephalopathyAcute on Chronic Liver Failure (ACLF)Decompensated Cirrhosis

Interventions

VS-01 on top of SOC (Active Treatment Group)

DRUG

SOC

DRUG

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

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Liver CirrhosisDecompensated Cirrhosis of Liver

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RECRUITINGNA

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

NCT06431919

Decompensated CirrhosisCirrhotic Cardiomyopathy+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy

Inclusion Criteria

Exclusion Criteria

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

Study About Hepatic Toxins Kinetic and Evaluation of Organ Damage in Acute on Chronic Liver Failure (ACLF) Patients

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Safety and Efficacy of Fecal Microbiota Transplantation