JPRN-jRCT1080224629已完成4 期
A MULTICENTER, OPEN-LABEL, POST-MARKETING STUDY TO EVALUATE THE LONG-TERM SAFETY AND JOINT HEALTH WITH ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS AGED LESS THAN 12 YEARS WITHOUT FVIII INHIBITORS
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 11age old（—）
- 性别
- All
入选标准
- •(1) Aged <12 years at the time of informed consent
- •(2) Body weight >3 kg at the time of informed consent
- •(3) Diagnosis of severe (endogenous FVIII level <1%) congenital hemophilia A
- •(4) Negative results for FVIII inhibitors (<0.6 BU/mL) in the most recent assay within 8 weeks prior to enrollment
排除标准
- •(1) Inherited or acquired bleeding disorder other than hemophilia A
- •(2) Current receipt of immune tolerance induction (ITI) therapy
- •(3) Previous (within the past 12 months) or current treatment for thromboembolic disease (except patients with previous catheter-associated thrombus who are not currently receiving treatment) or signs of thromboembolic disease
研究者
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