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Completed

NCT Number: NCT02946554

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

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.

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Key information

Conditions

Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HepaStem

Biological

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cellaion SA

Industry

Registry information

Official study title

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

Acronym: HEP101

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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