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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

NCT06987968 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-01-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pejvack MOTLAGH, M.D, M.Sc · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2025-09-08
Completion
2025-09-15
FDA Drug
Yes

Countries

  • United States
  • France
  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987968 on ClinicalTrials.gov