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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04229901
Other study ID # HEP102
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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%.

Study Design


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
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