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.

Primary study objective: To evaluate the safety of multiple intravenous administration of recombinant human albumin in patients with cirrhosis and hypoalbuminemia. Secondary study objective: To evaluate the immunogenicity of recombinant human albumin in patients with cirrhosis and hypoalbuminemia.