Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF

Acute-On-Chronic Liver Failure Clinical Trial

— HEP101  

Official title:

Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946554
• Other study ID #: HEP101
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: Promethera Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Main Inclusion Criteria:

• Diagnosed cirrhosis

• Patient with Acute Decompensation of cirrhosis

• Serum total Bilirubin = 6 mg/dL (=100 umol/L)

• The INR measurement has to be : 1.2 = INR < 2

Main Exclusion Criteria:

• Absence of portal vein flow

• Known or medical history of thrombotic events

• Gastrointestinal hemorrhage requiring blood transfusion

• Variceal bading or sclerosis within 4 weeks before infusion

• Septic shock or non-controlled bacterial infection

• Clinical evidence of aspergilus infection.

• Circulatory failure

• Respiratory disordered

• Coagulation disorders defined as INR = 2, Fibrinogen < 100 mg/dL or Platelets < 50.000/mm3

• MELD score > 30.

• Major invasive procedure within 4 weeks before infusion

• Previous organ transplantation and/or ongoing immunosuppressive treatments.

• Renal failure due to chronic kidney disease.

• Clinically significant left-right cardiac shunt.

Related Conditions & MeSH terms

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

Intervention

Biological:
• HepaStem

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	CHU Brugmann	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	KU Leuven	Leuven
Belgium	CHU de Liège	Liège
Belgium	Cliniques St Luc	Woluwe-Saint Lambert
France	Hôpital Beaujon	Clichy
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Promethera Biosciences

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period		up to 28Day post first infusion day
Secondary	Efficacy assessed by clinical parameters	Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.	28Day, 3 month and 1 year post first infusion day
Secondary	Efficacy assessed by biological parameters	Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values	28Day, 3 month and 1 year post first infusion day
Secondary	Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest	Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal	3 month and 1 year post first infusion day