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

NCT04229901 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-05-22

No results posted yet for this study

Summary

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 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.

Conditions

  • Acute on Chronic Liver Failure

Interventions

DRUG

HepaStem

HepaStem will be administered as an intravenous (IV) infusion

DRUG

Placebo

Placebo will be administered as an intravenous (IV) infusion

Sponsors & Collaborators

  • Cellaion SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2024-05-10
Completion
2024-05-10

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • North Macedonia
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT04229901 on ClinicalTrials.gov