NCT06411743

Phase II/III of Recombinant Human Albumin Injection

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatic Ascites

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Albumin Injection	Recombinant Human Albumin injection, strength: 10 g/vial (20%, 50 mL); storage conditions: 2-8°C, protected from light; manufactured and supplied by Tonghua Anrate Biopharmaceutical Co., Ltd.
BIOLOGICAL	Human Albumin	Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS Blood Products Co., Ltd.

Timeline

• Start date: 2021-09-07
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2024-05-13
• Last updated: 2024-05-13

Locations

1 site across 1 country: China