Hepatic Ascites Clinical Trial
Official title:
To Evaluate the Effectiveness of Recombinant Human Serum Albumin Versus Human Serum Albumin in Patients With Hepatic Cirrhosis and Safety of Random, Double-blind, Parallel Grouping Phase II/III Clinical Trial
This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.
This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients. It is divided into two phases: Phase II and Phase III. In phase II, the effect of rHSA on improving serum albumin level in cirrhotic ascites patients will be evaluated with different doses and courses of treatment, and the relationship between dose and efficacy will be determined, so as to provide basis for drug administration plan and sample size calculation of phase III study. In phase III, the efficacy of rHSA will be evaluated with the change of serum albumin concentration from baseline immediately after the completion of the last intravenous administration as the main index, and its safety, PD characteristics and immunogenicity will be further evaluated. ;
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