This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver). The study will recruit approximately 40 acute or acute-on-chronic liver failure patients.
Patient should have acute or acute-on-chronic liver failure and be registered in KONOS (Korean Network for Organ Sharing) system as a candidate of liver transplantation. Patients who meet the eligibility criteria will be assigned to control group or experimental group. Experimental group patients will receive LifeLiver treatment in addition to the best supportive care for the disease. Primary Objective: 1\. To evaluate the efficacy of LifeLiver in terms of a comparison of 30 day-survival rate between control group and experimental group. (after patient's KONOS (Korean Network for Organ Sharing) registration date) Secondary Objective: 1. To compare a median value of 2 week-survival rate and duration of survival between both study groups 2. Survival analysis respect to each group of patients divided according to the KONOS status 3. To investigate safety and change of overall efficacy indicators in terms of Glasgow Coma Scale, West Heaven Criteria for hepatic encephalopathy, MELD (Model for End-stage Liver Disease) score, blood ammonia, inflammatory cytokine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
LifeLiver is an extracorporeal bioartificial liver (BAL) system. The system has shown remarkable detoxification capacity and sustained hepatic functions and also provides a bridge to transplant for patients who are unable to receive timely liver transplantation.
Samsung Medical Center
Seoul, South Korea
RECRUITINGSurvival rate for 30 days
To compare survival rate of LifeLiver treatment with best supportive care
Time frame: up to 30 days
Occurrence of clinical safety laboratory adverse events (AEs)
To compare occurrence of clinical safety laboratory adverse events between Experimental group and Control group assessed according to NCI-CTCAE v5.0
Time frame: up to approximately 12 months
Incidence of transition of PERV (Porcine Endogenous Retrovirus) (for experimental group only)
Number of reported PERV transition defined as viral detection in subject's blood by PCR (Polymerase Chain Reaction) test.
Time frame: up to approximately 12 months
Survival rate for 14 days
To compare survival rate of LiveLiver treatment with best supportive care
Time frame: up to 14 days
Median value of duration of survival
To compare Median value of duration of survival between experimental group and control group
Time frame: up to approximately 12 months
Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37
To compare Kaplan-Meier estimate of both (experimental and control) groups at 14 days and 30 days
Time frame: up to 30 days
Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37
To compare Kaplan-Meier estimate of both groups at 14 days and 30 days
Time frame: up to 30 days
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Comparison of MELD score
Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's MELD score (range of minimum 6 to maximum 40)
Time frame: up to approximately 12hours after completion of LifeLiver treatment
Comparison of subject's neurological status - hepatic encephalopathy grade
Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's hepatic encephalopathy grade (range of minimum 1 to maximum 4)
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's neurological status - Glasgow Coma Scale
Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's Glasgow Coma Scale (range of minimum 3 to maximum 15)
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of blood ammonia
Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of blood ammonia
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of inflammatory cytokines
Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of inflammatory cytokines (TNF-α, Interleukin-6, Interleukin-10)
Time frame: up to approximately 12 hours after completion of LifeLiver treatment