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

NCT ID: NCT06987968

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2025-09-15

Brief 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

Conditions

Hepatic Encephalopathy; Acute on Chronic Liver Failure (ACLF); Decompensated Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VS-01 with 3 hours Dwell time+ Standard of Care (SOC)

Patients randomized to Active Treatment group will receive VS-01 3 hours Dwell time on top of SOC

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Patients will received VS-01 intraperitoneally up to four consecutive days on top of SOC

VS-01 with 4 hours Dwell time+SOC

Patients randomized to Active Treatment group will receive VS-01 4 hours Dwell time on top of SOC

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Patients will received VS-01 intraperitoneally up to four consecutive days on top of SOC

SOC

Patients randomized to Control group will receive SOC alone

Group Type: OTHER

SOC

Intervention Type: DRUG

Patients will received SOC

Interventions

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

Patients will received VS-01 intraperitoneally up to four consecutive days on top of SOC

Intervention Type: DRUG

SOC

Patients will received SOC

Intervention Type: DRUG

Eligibility Criteria

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);

11. Need for Renal replacement therapy (RRT) or any extracorporeal liver support device;

12. Any significant disease considered to be potentially detrimental or would preclude the patient from participating in and completing the study as assessed by the PI. 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. Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the patient;

14. Pregnancy or lactation;

15. Women of childbearing potential and non-sterile male patients who are not willing to use adequate contraception from SCR to 30 days after the final dose of investigational medicinal product (IMP);

16. Participation in another interventional clinical trial within 30 days of SCR.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genfit

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pejvack MOTLAGH, M.D, M.Sc

Role: STUDY_DIRECTOR

Genfit

Locations

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

Countries

United States; France; Georgia

Other Identifiers

2025-521029-34-00

Identifier Type: OTHER

Identifier Source: secondary_id

VS01_P2_24_2

Identifier Type: -

Identifier Source: org_study_id