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

Inclusion criteria

• 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 criteria

• 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;