NCT06553456

Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites

Random, Double-blind, Parallel Group Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.

Detailed description

This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites. In this trial（phase III）, the efficacy of rHSA will be evaluated by the change in serum albumin concentration immediately after the last intravenous administration from baseline, 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 was administered at a dose of 20 g/ day for 7 days.
DRUG	Human Serum Albumin	The positive control drug was administered at a dose of 20 g/ day for 7 days.

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2024-08-14
• Last updated: 2026-03-10

Locations

61 sites across 1 country: China