Evaluation of the efficacy and safety of human coagulation factor Ⅷ in the treatment of hemophilia A patients

• Published in: Zhongguo shu xue za zhi Vol. 35; no. 12; pp. 1220 - 1225
• Main Authors: Ruyi CHEN, Yan WU, Yiyun LIU, Mingxia HOU, Qingshuang SONG, Xuanlin ZHONG, Xueyun WANG, Wenjie XIE, Caiping GUO, Zhan ZHANG, Yunjia ZHANG
• Format: Journal Article
• Language: Chinese
• Published: Institute of Blood Transfusion of Chinese Academy of Medical Sciences 01-12-2022
• Subjects: efficacy; hemophilia a; human coagulation factor; safety
• ISSN: 1004-549X
• DOI: 10.13303/j.cjbt.issn.1004-549x.2022.12.008

Objective To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. Methods A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. Results The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the f