Phase II/III of Recombinant Human Albumin Injection

Hepatic Ascites Clinical Trial

Official title: A Phase II/III Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites

Status Completed

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. ;

Related Conditions & MeSH terms

• Ascites
• Hepatic Ascites

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