Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Promethera Biosciences

Criteria

Main Inclusion Criteria:

• Initial diagnostic of ACLF, at the investigational site, maximum 3 days before signature of the ICF.

• Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*.

• Bilirubin value ≥5 mg/dL.

Main Exclusion Criteria:

• ACLF grade 3.

• Active uncontrolled bleeding or patient with high risk of short term bleeding up to investigator's judgment.

• Model for End-Stage Liver Disease (MELD) score >35.

• Cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the screening and not considered stabilized by the investigator.

• Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy.

• Inability to maintain mean BP >60 despite use of vasopressors.

• Patients receiving immunosuppressive drugs, except glucocorticoids.

• Thrombosis of portal vein.

• Underlying cirrhosis due to biliary disease or auto immune hepatitis

• Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al. 2016):

1. fibrinogen <80 mg/dL

2. platelets <50 x 10³/mm3