JPRN-jRCT2080223336已完成3 期
A MULTICENTER, OPEN-LABEL, PHASE III STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB GIVEN EVERY 4 WEEKS (Q4W) IN PATIENTS WITH HEMOPHILIA A
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
Emicizumab given once every 4 weeks showed clinically meaningful bleed control while being well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Aged 12 years or older at the time of informed consent
- •2)Body weight >= 40 kg at the time of screening
- •3)Diagnosis of severe congenital hemophilia A or hemophilia A with FVIII inhibitors
排除标准
- •1)Inherited or acquired bleeding disorder other than hemophilia A
- •2)Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
- •3)Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
- •4)History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
研究者
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