JPRN-jRCT2080223290已完成3 期
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITHOUT INHIBITORS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
研究概览
简要总结
The administration of emicizumab once weekly or every 2 weeks was associated with significantly lower bleeding rates than the rate with no prophylaxis.
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 (intrinsic FVIII level <1%)
- •4) No documented inhibitor (>= 0.6 BU) in the last 5 years
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
- •diseaseOngoing (or plan to receive during the study) immune tolerance induction therapy or prophylaxis with FVIII
- •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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