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

Phase 2

Completed

• Conditions: Acute-On-Chronic Liver Failure

• Registration Number: NCT02946554
• Lead Sponsor: Cellaion SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2016-12
• Primary Completion: 2019-07
• Study Completion: 2020-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest	3 month and 1 year post first infusion day	Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Efficacy assessed by clinical parameters	28Day, 3 month and 1 year post first infusion day	Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Efficacy assessed by biological parameters	28Day, 3 month and 1 year post first infusion day	Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values

Trial Locations

Locations (10)

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, Belgium

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France