drugset / Trial / NCT06553456

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

NCT06553456

Phase 2/3 Completed 390 enrolled Protgen Ltd
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-08-19
Primary completion
2025-05-14
Completion
2025-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED Protein / enzyme biologic 20 g Intravenous
Comparator Human serum albumin Protein / enzyme biologic 20 g

Indications