[Translation] The efficacy and safety of plant-derived recombinant human serum albumin injection in cirrhotic patients with hypoalbuminemia multicenter, randomized, double-blind, positive-controlled phase III clinical study
主要目的:
评价植物源重组人血清白蛋白注射液对肝硬化低白蛋白血症患者升高血清白蛋白浓度的有效性。
次要目的:
评价植物源重组人血清白蛋白注射液在肝硬化低白蛋白血症患者中的安全性;
评价植物源重组人血清白蛋白注射液在肝硬化低白蛋白血症患者中的免疫原性。
[Translation] main purpose:
To evaluate the effectiveness of plant-derived recombinant human serum albumin injection in increasing serum albumin concentration in patients with liver cirrhosis and hypoalbuminemia.
Secondary purpose:
To evaluate the safety of plant-derived recombinant human serum albumin injection in patients with liver cirrhosis and hypoalbuminemia;
To evaluate the immunogenicity of plant-derived recombinant human serum albumin injection in patients with liver cirrhosis and hypoalbuminemia.