This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure(ACLF). Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively. Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.
Using DPMAS and LPE for extracorporeal dialysis treatment.
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGSafety outcome
Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.(Phase I)
Time frame: From the initiation of treatment until 14 days after the end of study treatment.]
survival rate
The survival rate without liver transplantation at 12 weeks after the first treatment.(PhaseⅡ) Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. (PhaseⅡ)
Time frame: 12 weeks after the initial treatment]
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