Condition: Acute on Chronic Hepatic Failure · Liver Failure · Hepatitis · Sponsor: Hexaell Biotech Co., Ltd.
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
This description comes directly from the study's public registry record.
YU Chen, MD · 8610-83997599 · chybeyond@163.com
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| Beijing You'an Hospital affiliated to Capital Medical University | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05989958