Multi-center clinical study to describe the relationship between anti-emicizumab antibodies and plasma emicizumab concentration and various coagulation tests

Chugai Pharmaceutical Co., Ltd0 个研究点目标入组 50 人开始时间: 2025年2月5日最近更新: 2025年4月22日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 50
主要终点: FVIII activity (emicizumab response)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: No limit 至 No limit（—）
性别: All

入选标准

•Patients who will be collected blood samples prospectively after study enrollment.
•Informed consent to participate in the study has been obtained from the patient personally or from a legal representative using the Informed Consent Form. If possible, assent to participate in the study will be obtained from pediatric patients personally using the Informed Assent Form.
•Diagnosis of congenital hemophilia A or acquired hemophilia A at the time of enrollment.
•Investigator have confirmed both of the following conditions at the time of blood sample submission to the Measurement Program prior to enrollment.
•a. Recieving emicizumab in accordance with the indications and dosage and administration of the package insert.
•b. Suspect of having a decreased plasma emicizumab concentration, as evidenced by prolonged APTT
•and increased bleeding frequency, etc.
•Patients who have been stored blood samples at the central laboratory and will not be collected new blood samples after study enrollment.
•Patients who meet any of the following criteria
•a. Informed consent to participate in the study has been obtained from the patient personally or from a legal representative
•using the Informed Consent Form. If possible, assent to participate in the study will be obtained from pediatric patients
•personally using the Informed Assent Form.
•b. Patients who have not indicated their refusal during the period when the documents regarding the clinical study and use of
•existing samples are posted on the website of the medical institution, etc.
•Diagnosis of congenital hemophilia A or acquired hemophilia A at the time of initial sample submission to the Measurement Program.
•Patients who Investigator have confirmed both of the following conditions at the first time of blood sample submission to the Measurement Program.
•a. Recieving emicizumab in accordance with the indications and dosage and administration of the package insert.
•b. Suspect of having a decreased plasma emicizumab concentration, as evidenced by prolonged APTT and increased bleeding
•frequency, etc.

排除标准

•Inherited or acquired bleeding disprder other than congenital hemophilia A and acquired hemophilia A
•In the judge of the investigator, patient would be unsuitable for study participation

结局指标

主要结局

FVIII activity (emicizumab response)

chromogenic assay using human coagulation factor

Anti-emicizumab antibodies

antibody titer and presence of neutralizing activity

FVIII activity (emicizumab non-response)

one-stage clotting assay of emicizumab-neutralizing activity

次要结局

FVIII activity (emicizumab non-response)
FVIII activity (emicizumab response)
Changes over time in anti-emicizumab antibody titers, coagulation test values and clinical findings

研究者

发起方

Chugai Pharmaceutical Co., Ltd

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