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The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Sponsor: Hexaell Biotech Co., Ltd.
Summary
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
Official title: A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2023-09-22
Completion Date
2026-09
Last Updated
2025-02-25
Healthy Volunteers
No
Interventions
HepaCure
HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.
DPMAS and LPE
Using DPMAS and LPE for extracorporeal dialysis treatment.
Locations (1)
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China