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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05858853
Study type Interventional
Source Protgen Ltd
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 25, 2023
Completion date September 6, 2023

See also
  Status Clinical Trial Phase
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Completed NCT04785755 - Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites Phase 2
Completed NCT05179265 - Recombinant Human Serum Albumin in Healthy Subjects Phase 1