Status:
RECRUITING
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Lead Sponsor:
Hexaell Biotech Co., Ltd.
Conditions:
Acute on Chronic Hepatic Failure
Liver Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.
- Age: ≥ 18 years and ≤ 65 years.
- Body weight: ≥ 40kg;
- Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol/L or increase ≥ 17.1 μmol/L daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%\<PTA ≤ 40% (or 1.5 ≤ INR\<2.6), and other reasons excluded.
Exclusion
- Subjects with primary or metastatic liver cancer.
- Subjects with severe esophageal/gastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.
- Serum creatinine was greater than 132.6 μmol/L.
- Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites\>0.1 × 10 9/L after reasonable antibiotic treatment), etc;
Key Trial Info
Start Date :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05989958
Start Date
September 22 2023
End Date
September 1 2026
Last Update
February 25 2025
Active Locations (1)
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1
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100069