JPRN-jRCT1031230480尚未招募未知
Multi-center clinical study to describe the relationship between anti-emicizumab antibodies and plasma emicizumab concentration and various coagulation tests
Keiji Nogami0 个研究点目标入组 50 人开始时间: 2023年11月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
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
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who have submitted blood samples to the plasma emicizumab concentration measurement program (hereinafter, Measurement Program) and will be collected blood samples prospectively after study enrollment.
- •1) 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.
- •2) Diagnosis of congenital hemophilia A or acquired hemophilia A at the time of enrollment.
- •3) 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 of the Measurement Program at the central laboratory and will not be collected new blood samples after study enrollment.
- •1) 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.
- •2) Diagnosis of congenital hemophilia A or acquired hemophilia A at the time of initial sample submission to the Measurement Program.
- •3) Blood samples submitted to the Measuremtn Program are stored at the central laboratoy, and investigator have confirmed both of the following conditions at the 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
- •1) Inherited or acquired bleeding disprder other than congenital hemophilia A and acquired hemophilia A
- •2) In the judge of the investigator, patient would be unsuitable for study participation
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