Phase Ib of Recombinant Human Albumin Injection

Phase 1 Completed 36 enrolled The First Hospital of Jilin University

RandomizedParallel-groupOpen-labelTreatment

Summary

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis

Timeline

Start: 2020-03-15
Primary completion: 2020-09-10
Completion: 2020-10-25

Publications

Wang X, Li W, Kong F, Guo X, Jin Q, Gao R, Hu Y, Cai Y, Xin G, Ji H, Piao H, Fu Z, Wang Y, Piao Z, Wang S, Hua R, Wen X, Qi Y, Jin J, Wang C, Wang Z, Xu F, Zhou Q, Li X, Yu G, Wang Y, Yang T, Xiang W, Pan Y, Niu J, Gao Y. A randomized, phase Ib trial of recombinant human serum albumin in cirrhotic patients with ascites. Hepatol Int. 2026 Feb;20(1):91-101. doi: 10.1007/s12072-025-10871-x. Epub 2025 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Albumin	Protein / enzyme biologic	10 g	Intravenous
Comparator	Albumin	Protein / enzyme biologic	20 g	Intravenous
Comparator	Albumin	Protein / enzyme biologic	30 g	Intravenous
Subject	HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED	Protein / enzyme biologic	10 g	Intravenous
Subject	HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED	Protein / enzyme biologic	20 g	Intravenous
Subject	HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED	Protein / enzyme biologic	30 g	Intravenous

Indications

No indication recorded.