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Clinical Trial Summary

This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.


Clinical Trial Description

This study was a Phase II/III multicenter, blinded, and positive-controlled clinical study with seamless adaptive design. The Phase II clinical study was conducted first, followed by the Phase III clinical study.The Phase II clinical study aimed to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and provide a reference for the design of Phase III clinical study. Dosage: For the 10 g/day rHA injection group, the subjects were administered rHA at a dose of 10 g/day once daily for 14 days. For the 20 g/day rHA injection group, the subjects were administered rHA at a dose of 20 g/day once daily for 7 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06411743
Study type Interventional
Source The First Hospital of Jilin University
Contact
Status Completed
Phase Phase 2
Start date September 7, 2021
Completion date August 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT05249374 - Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects Phase 1
Completed NCT04785755 - Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites Phase 2
Completed NCT05858853 - Phase II/III of Recombinant Human Serum Albumin Phase 2/Phase 3
Completed NCT05179265 - Recombinant Human Serum Albumin in Healthy Subjects Phase 1