NCT05858853

Phase II/III of Recombinant Human Serum Albumin

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cirrhotic Ascites

Interventions

Type	Name	Description
DRUG	Recombinant Human Serum Albumin	The experimental drug (recombinant human serum albumin injection) was administered 10 g/ day for 14 days
DRUG	Recombinant Human Serum Albumin	The experimental drug (recombinant human serum albumin injection) was administered 20 g/ day for 7 days
DRUG	Human serum albumin	Control drug (human blood albumin injection) 10 g/ day for 14 days
DRUG	Human serum albumin	Control drug (human blood albumin injection) 20 g/ day for 7 days

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2023-05-15
• Last updated: 2026-03-10

Locations

25 sites across 1 country: China