A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)

Genfit26 sites in 7 countries15 target enrollmentJuly 2, 2023

ConditionsAcute-On-Chronic Liver Failure Ascites

InterventionsVS-01 on top of SOC SOC (Control Group)

DrugsVS-01 on top of SOC

Overview

Phase: Phase 2
Intervention: VS-01 on top of SOC
Conditions: Acute-On-Chronic Liver Failure
Sponsor: Genfit
Enrollment: 15
Locations: 26
Primary Endpoint: Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7
Status: Terminated
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

July 2, 2023

End Date

October 15, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genfit

Responsible Party

Sponsor

Eligibility Criteria

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

•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:
•Respiratory failure necessitating invasive mechanical ventilation;
•Coagulation failure (INR \> 3.2 or platelet count ≤20 x 109/L);
•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;

Arms & Interventions

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

Patients randomized to Active Treatment group will receive VS-01 on top of SOC

Intervention: VS-01 on top of SOC

SOC (Control Group)

Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF

Intervention: SOC (Control Group)

Outcomes

Primary Outcomes

Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7

Time Frame: 7 days

Secondary Outcomes

Transplant-free survival through/at Days 28 and 90(Day 1 through Days 28 and 90, at Day 28 and 90)
Time to death through Days 28 and 90(Day 1 through Days 28 and 90)
28-day and 90-day mortality(At Days 28 and 90)
Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.(Day 0 to Day 90)
Change in ACLF grade through/at Days 7 and 28(Day 1 through Day 7 and Day 28, at Days 7 and 28)