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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: The study will assess the safety of two dose regimens of HepaStem in Patients with ACLF up to Day 28 of the active study period.

Detailed Summary:
Sponsor: Promethera Biosciences

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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
• 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

Original Secondary Outcome: Same as current

Information By: Promethera Biosciences

Dates:
Date Received: October 13, 2016
Date Started: October 2016
Date Completion: September 2018
Last Updated: October 25, 2016
Last Verified: October 2016