NCT06987968

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	VS-01 on top of SOC (Active Treatment Group)	Patients will received VS-01 intraperitoneally up to four consecutive days on top of SOC
DRUG	SOC	Patients will received SOC

Timeline

• Start date: 2025-08-25
• Primary completion: 2025-09-08
• Completion: 2025-09-15
• First posted: 2025-05-23
• Last updated: 2026-01-12

Locations

6 sites across 3 countries: United States, France, Georgia

Regulatory

• FDA-regulated drug study