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

  • STATUS
    Recruiting
  • End date
    Jan 23, 2023
  • participants needed
    363
  • sponsor
    Promethera Therapeutics
Updated on 23 March 2022
dose regimen

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.

Details
Condition Acute on Chronic Liver Failure
Treatment Placebo, HepaStem
Clinical Study IdentifierNCT04229901
SponsorPromethera Therapeutics
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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

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)
fibrinogen <80 mg/dL
platelets <50 x 10³/mm3
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