A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites
brief summary
This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.
detailed description
This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.After the primary efficacy endpoint ALB reaches the equivalence standard (-2 g/L to 2 g/L, test drug - control drug), a non-inferiority judgment will be made for the key secondary efficacy endpoint of the improvement rate of ascites depth (\> -10%, test drug - control drug). Dosage: 20 g/day once daily for 7 days.
official title
A Phase III Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites