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Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (HEP101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946554
Recruitment Status : Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Promethera Biosciences

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.

Condition or disease Intervention/treatment Phase
Acute-On-Chronic Liver Failure Biological: HepaStem Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Low dose cohort

Two dose regimens of HepaStem will be given, which differ in the amount of cells per infusion.

The low dose regimen will be given to the first cohort (first 6 patients included in the study).

Biological: HepaStem
High dose cohort
The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)
Biological: HepaStem



Primary Outcome Measures :
  1. Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period [ Time Frame: up to 28Day post first infusion day ]

Secondary Outcome Measures :
  1. Efficacy assessed by clinical parameters [ Time Frame: 28Day, 3 month and 1 year post first infusion day ]
    Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.

  2. Efficacy assessed by biological parameters [ Time Frame: 28Day, 3 month and 1 year post first infusion day ]
    Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values

  3. Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest [ Time Frame: 3 month and 1 year post first infusion day ]
    Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946554


Locations
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Belgium
Hôpital Erasme
Brussels, Belgium, 1070
CHU Brugmann
Bruxelles, Belgium, 1020
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
KU Leuven
Leuven, Belgium, 3000
CHU de Liège
Liège, Belgium, 4000
Cliniques St Luc
Woluwe-Saint Lambert, Belgium, 1200
France
Hôpital Beaujon
Clichy, France, 92110
Hôpital de la Croix Rousse
Lyon, France, 69004
Hôpital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
Promethera Biosciences

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Responsible Party: Promethera Biosciences
ClinicalTrials.gov Identifier: NCT02946554    
Other Study ID Numbers: HEP101
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by Promethera Biosciences:
Acute-On-Chronic Liver Failure
ACLF
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute