Tonghua Anrate Biopharmaceutical Co., Ltd.

The main purpose of the Phase III trial: Using the change of serum ALB after treatment as an indicator, compare the efficacy equivalence of recombinant human albumin (rHA) and human serum albumin (HSA) injection in patients with cirrhosis and ascites. The key secondary objectives of the Phase III trial: Using the effective rate of comprehensive clinical improvement after treatment as an indicator, prove that the efficacy of rHA injection in patients with cirrhosis and ascites is non-inferior to HSA injection. The secondary objectives of the Phase III trial: Evaluate the safety of rHA and HSA injection in patients with hypoalbuminemia in cirrhosis and ascites; Based on the secondary efficacy endpoints, evaluate the efficacy of rHA and HSA injection in patients with hypoalbuminemia in cirrhosis and ascites; Evaluate the immunogenicity of rHA and HSA injection in patients with hypoalbuminemia in cirrhosis and ascites. During the follow-up period of the study, explore the retreatment of rHA and HSA and the efficacy of retreatment.

The main purpose of the Phase II trial is to evaluate the preliminary efficacy of recombinant human albumin injection in improving serum albumin levels in patients with cirrhosis and ascites, as well as the relationship between dose and efficacy; to evaluate the safety of recombinant human albumin injection in patients with cirrhosis and ascites. The secondary objectives of the Phase II trial are to evaluate the efficacy of recombinant human albumin injection using the proportion of subjects with serum albumin (ALB) reaching 35 g/L, the time required for serum ALB to reach 35 g/L, the improvement of subject weight, the change in the depth of ascites in subjects, and the change in the waist circumference of subjects as secondary efficacy indicators; to evaluate the changes in plasma colloidal osmotic pressure of subjects; and to evaluate the immunogenicity of recombinant human albumin injection in patients with cirrhosis and ascites. The main purpose of the Phase III trial is to evaluate the efficacy of recombinant human albumin injection in patients with cirrhosis and ascites using the changes in serum ALB after treatment as an indicator. The secondary objectives of the Phase III trial are: to evaluate the safety of recombinant human albumin injection in patients with cirrhosis and ascites; to evaluate the efficacy of recombinant human albumin injection using the proportion of subjects whose serum ALB reaches 35 g/L, the time required for serum ALB to reach 35 g/L, the improvement in subjects' body weight, the change in the depth of ascites in subjects, and the change in the waist circumference of subjects as secondary efficacy indicators; to evaluate the changes in the subjects' plasma colloidal osmotic pressure; and to evaluate the immunogenicity of recombinant human albumin injection in patients with cirrhosis and ascites.

Primary objective: To evaluate the safety and tolerability of recombinant human albumin injection in the treatment of patients with liver cirrhosis and ascites. Secondary objective: To evaluate the preliminary efficacy, pharmacodynamics, pharmacokinetic characteristics and immunogenicity of recombinant human albumin injection in patients with liver cirrhosis and ascites.