The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure

Inclusion Criteria:

1. Able to communicate effectively with investigators and sign the informed consentform (ICF) voluntarily.

2. Age: ≥ 18 years and ≤ 65 years.

3. Body weight: ≥ 40kg;

4. 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 onchronic liver disease, acute jaundice deepened and coagulation dysfunction caused byvarious inducements, manifested as extreme fatigue, with obvious gastrointestinalsymptoms such as anorexia, vomiting, abdominal distention, etc; Progressivedeepening 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 otherreasons excluded.

Exclusion Criteria:

1. Subjects with primary or metastatic liver cancer.

2. Subjects with severe esophageal/gastric varices and high risk of bleeding, withpositive red signs, or with previous active bleeding, as indicated by gastroscopy orimaging examination results.

3. Serum creatinine was greater than 132.6 μmol/L.

4. Subjects with serious uncontrolled infections, including sepsis, septic shock,severe pneumonia (refers to the diagnostic criteria of the American Society ofInfectious Diseases/American Thoracic Society for adult severe pneumonia in 2007),abdominal infection (exist Peritonitis manifestations or white blood cells inascites>0.1 × 10 9/L after reasonable antibiotic treatment), etc;