Assessment of coagulation potential of concomitantly used factor VIII concentrates in hemophilia A patients with emicizumab prophylaxis (CAGUYAMA Study)

未提供0 个研究点目标入组 100 人开始时间: 2022年1月17日最近更新: 2025年1月7日

试验速览

暂无简介。

•Congenital hemophilia A patients without inhibitor over 4 years old
•Patients receiving emicizumab 5 times or more based on the latest package insert
•Patients who have received sufficient explanation about the contents of this clinical study, and have obtained written consent from the study patients or their legal guardian
•Patients who can comply with the planned procedure in this clinical study

•Patients who have difficulty in regular visits and/or visits at the events
•Patients with other diseases with abnormal liver function or platelet count (AST and/or ALT are 5 times or more of the normal upper limit. Platelet count<100,000/microliter)
•Patients with extremely difficult blood collection
•Patients who are judged by the investigator to be inappropriate for some reasons

Maximum coagulation velocity

by modified clot waveform analysis after administration of FVIII product

Evaluation of hemostasis status in clinical symptoms
Coagulation parameters before and after administration of FVIII product with and without addition of anti-emicizumab antibody(before and after administration)
Coagulation parameters at the time of registration and before administration of FVIII product with or without addition of anti-emicizumab antibody(at the time of registration and before administration)
General coagulation parameters and blood level of emicizumab in blood samples before and after administration of FVIII product(before and after administration)
General coagulation parameters and blood level of emicizumab in blood samples at the time of registration and before administration of FVIII product(at the time of registration and before administration)

发起方

未提供