Hemophilia A in infancy and newborns; multi-institutional prospective observational study to assess the efficacy and safety of emicizumab

ogami Keiji0 个研究点目标入组 50 人开始时间: 2023年7月29日最近更新: 2024年1月22日

试验速览

暂无简介。

•Inclusion criteria;
•1)Patientss for whom consent to participate in the study has been obtained from proxy consenters by means of written informed consent
•2) Confirmed diagnosis with Congenital haemophilia A at enrollment.
•3)Patients selected for the treatment with emicizumab as the most appropriate medical treatment (those who planned to receive emicizumab treatment in the selection of the treatment between physicians and patients) and who are receiving or scheduled to receive emicizumab according to the current electronic package insert dosage and administration.
•4)Patients who have reached or are likely to reach the maintenance phase* of emicizumab at less than 12 months of age and are able to obtain blood samples in the maintenance phase* of less than 12 months of age.
•*The maintenance phase in this study refers to the fifth and subsequent doses of emicizumab.

•Exclusion criteria;
•1)Patients with inherited or acquired bleeding disorders other than haemophilia A.
•2)Patients to be inappropriate to enter this study for some other reason judged by the investigators.

发起方

ogami Keiji