drugset
drugset / Trial / NCT06411743

Phase II/III of Recombinant Human Albumin Injection

NCT06411743 ↗

Phase 2 Completed 90 enrolled The First Hospital of Jilin University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-09-07
Primary completion
2022-08-15
Completion
2022-08-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic 10 g —
Comparator Albumin Protein / enzyme biologic 20 g —
Subject Recombinant Human Albumin Protein / enzyme biologic 10 g —
Subject Recombinant Human Albumin Protein / enzyme biologic 20 g —

Indications

No indication recorded.