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

Acute on Chronic Liver Failure Clinical Trial

— DHELIVER  

Official title:

Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04229901
• Other study ID #: HEP102
• Status: Terminated
• Phase: Phase 2
• Start date: January 21, 2020
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Cellaion SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Are adults aged between 18 and 75 years old.

2. Have an initial diagnosis of ACLF at the investigational site.

3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.

4. Have a total bilirubin = 5 mg/dL.

5. Are able to read, understand and give written informed consent.

Main Exclusion Criteria:

1. Have a MELD-Na score > 35.

2. Have underlying cirrhosis due to biliary disease.

3. Have underlying cirrhosis due to autoimmune hepatitis.

4. 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.

5. 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.

6. Have a complete portal vein thrombosis.

7. Have coagulation disturbances defined as:

• fibrinogen < 80 mg/dL

• platelets < 50 x 10³/mm³

8. Are requiring chronic dialysis therapy.

9. 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.

10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) = 40%.

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• HepaStem
HepaStem will be administered as an intravenous (IV) infusion
• Placebo
Placebo will be administered as an intravenous (IV) infusion

Locations

Country	Name	City	State
Austria	Medical University Of Vienna	Vienna
Belgium	UZ Antwerpen	Antwerp
Belgium	CHU Brugmann	Brussels
Belgium	CHU Erasme	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHC MontLégia	Liège
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert
Bulgaria	University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"	Pleven
Bulgaria	UMHAT Medica	Ruse
Bulgaria	Military Medical Academy	Sofia
Bulgaria	UMHAT Sveta Anna	Sofia
Bulgaria	UMHAT Tzarita Joanna	Sofia
Denmark	Aarhus University Hospital	Aarhus
Estonia	Lääne-Tallinna Keskhaigla AS	Tallinn
Estonia	North Estonia Regional Hospital	Tallinn
France	CHU Angers	Angers
France	Hopital Beaujon	Clichy
France	Assistance Publique Hopitaux De Paris	Créteil
France	Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
France	Hospices Civils De Lyon	Lyon
France	Assistance Publique Hopitaux De Marseille	Marseille
France	CHU Montpellier	Montpellier
France	Assistance Publique-Hopitaux de Paris - Hopitaux Universitaires Pitie-Salpetriere	Paris
France	Les Hopitaux Universitaires De Strasbourg	Strasbourg
France	CHU De Toulouse	Toulouse
France	Hospital Paul Brousse	Villejuif
Germany	Medizinische Hochschule Hannover	Hanover
Germany	University Hospital Of Leipzig	Leipzig
Germany	University Hospital Of Ulm AöR	Ulm
Italy	Azienda Ospedaliera Ospedale Niguarda CA' Granda	Milan
Italy	Azienda Ospedaliera Universitaria Policlinico	Palermo
Italy	Azienda Sanitaria Universitaria Friuli Centrale	Udine
Latvia	Pauls Stradins Clinical University Hospital	Riga
Lithuania	Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinikos	Kaunas
North Macedonia	PHI General City Hospital "8mi Septemvri"	Skopje
North Macedonia	PHI University Clinic of Gastroenterohepatology	Skopje
Poland	Id Clinic	Myslowice
Poland	Kliniczny Szpital Wojewódzki Nr 2 Im. Sw. Jadwigi Królowej W Rzeszowie	Rzeszów
Slovakia	F.D. Roosevelt University General Hospital Of Banská Bystrica	Banská Bystrica
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	University Hospital Ramón Y Cajal	Madrid
Spain	Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda
Spain	Sabadell Hospital	Sabadell
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Unviersitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Cellaion SA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Liver transplant-free survival		Day 90
Secondary	Transplant-free survival while free of ACLF		Day 90
Secondary	Transplant-free survival with MELD-Na score < 15		Day 90
Secondary	Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization		up to Day 90

External Links

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