Actively Recruiting
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Led by Hexaell Biotech Co., Ltd. · Updated on 2025-02-25
92
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate effectively and voluntarily sign informed consent
- Aged between 18 and 65 years
- Body weight of at least 40 kg
- Diagnosed with early or middle stage acute-on-chronic liver failure based on specific clinical criteria including jaundice and coagulation problems
You will not qualify if you...
- Presence of primary or metastatic liver cancer
- Severe esophageal or gastric varices with high bleeding risk or previous active bleeding
- Serum creatinine greater than 132.6 bcmol/L
- Serious uncontrolled infections such as sepsis, septic shock, severe pneumonia, or abdominal infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100069
Actively Recruiting
Research Team
Y
YU Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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