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

NCT04229901 | Terminated Phase 2 DMC

• 1 other identifier: HEP102
• Study Type: interventional
• Target: 133
• Locations: 13 countries
• Sites: 45

Brief 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

Keywords

ACLF; Hepastem; HALPC

Outcome Measures

Primary Outcomes (1)

• Survival

  Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.

  Day 90

Secondary Outcomes (4)

• Liver transplant-free survival

  Day 90

• Transplant-free survival while free of ACLF

  Day 90

• Transplant-free survival with MELD-Na score < 15

  Day 90

• Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization

  up to Day 90

Study Arms (2)

HepaStem

EXPERIMENTAL

Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval)

Drug: HepaStem

Placebo

PLACEBO COMPARATOR

Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)

Drug: Placebo

Interventions

HepaStem DRUG

HepaStem will be administered as an intravenous (IV) infusion

HepaStem

Placebo DRUG

Placebo will be administered as an intravenous (IV) infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are adults aged between 18 and 75 years old.
• Have an initial diagnosis of ACLF at the investigational site.
• Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
• Have a total bilirubin ≥ 5 mg/dL.
• Are able to read, understand and give written informed consent.

You may not qualify if:

• Have a MELD-Na score \> 35.
• Have underlying cirrhosis due to biliary disease.
• Have underlying cirrhosis due to autoimmune hepatitis.
• Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
• Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
• Have a complete portal vein thrombosis.
• Have coagulation disturbances defined as:
• fibrinogen \< 80 mg/dL
• platelets \< 50 x 10³/mm³
• Are requiring chronic dialysis therapy.
• Have had a 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.
• Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.

Sponsors & Collaborators

• Cellaion SA: lead

Study Sites (47)

Medical University Of Vienna

Vienna, 1090, Austria

Location

UZ Antwerpen

Antwerp, Belgium

Location

CHU Brugmann

Brussels, Belgium

Location

CHU Erasme

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHC MontLégia

Liège, Belgium

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Location

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"

Pleven, Bulgaria

Location

UMHAT Medica

Rousse, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

UMHAT Sveta Anna

Sofia, Bulgaria

Location

UMHAT Tzarita Joanna

Sofia, Bulgaria

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

North Estonia Regional Hospital

Tallinn, 13419, Estonia

Location

Lääne-Tallinna Keskhaigla AS

Tallinn, Estonia

Location

CHU Angers

Angers, France

Location

Hopital Beaujon

Clichy, France

Location

Assistance Publique Hopitaux De Paris

Créteil, 94000, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Hospices Civils De Lyon

Lyon, France

Location

Assistance Publique Hopitaux De Marseille

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

Assistance Publique-Hopitaux de Paris - Hopitaux Universitaires Pitie-Salpetriere

Paris, France

Location

Les Hopitaux Universitaires De Strasbourg

Strasbourg, France

Location

CHU De Toulouse

Toulouse, 31059, France

Location

Hospital Paul Brousse

Villejuif, 94804, France

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

University Hospital Of Leipzig

Leipzig, 04103, Germany

Location

University Hospital Of Ulm AöR

Ulm, 89081, Germany

Location

Azienda Ospedaliera Ospedale Niguarda CA' Granda

Milan, 20162, Italy

Location

Azienda Ospedaliera Universitaria Policlinico

Palermo, 90127, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Lietuvos Sveikatos Mokslų Universiteto Ligoninė Kauno Klinikos

Kaunas, 50161, Lithuania

Location

PHI General City Hospital "8mi Septemvri"

Skopje, 1000, North Macedonia

Location

PHI University Clinic of Gastroenterohepatology

Skopje, 1000, North Macedonia

Location

Id Clinic

Mysłowice, 41-400, Poland

Location

Kliniczny Szpital Wojewódzki Nr 2 Im. Św. Jadwigi Królowej W Rzeszowie

Rzeszów, 35-301, Poland

Location

F.D. Roosevelt University General Hospital Of Banská Bystrica

Banská Bystrica, 974 01, Slovakia

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

University Hospital Ramón Y Cajal

Madrid, 28049, Spain

Location

Hospital Universitario Puerta De Hierro De Majadahonda

Majadahonda, 28222, Spain

Location

Sabadell Hospital

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Unviersitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: January 21, 2020
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); IT (3); ES (7); LA (1); LI (1); DE (3); NO (2); SL (1); BU (5); PL (2); BE (7); AU (1); FR (11)