2024-515622-80-00招募中3 期
A Phase III, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Prophylaxis in Patients with Type 3 Von Willebrand Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 14
- 主要终点
- Number of treated bleeds over time
研究概览
简要总结
To evaluate the efficacy of prophylactic emicizumab (i.e., administered on a scheduled basis with the intent to prevent bleeds) over time compared with on-demand standard of care (SOC) based on the superiority assessment of the following primary endpoint
研究设计
- 分配方式
- Not Applicable
- 主要目的
- A Phase Iii, Multicenter, Open-label Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And P
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 2 years at the time of signing Informed Consent/Assent Form
- •Adequate hematological function
- •Documented exposure to on-demand and prophylactic SOC
- •For patient with childbearing potential; agreement to adhere to the contraception requirements
- •Confirmed diagnosis of Type 3 VWD, based on evaluation of VWF and FVIII levels
- •Status of VWF inhibitor
排除标准
- •Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
- •History of intracranial hemorrhage
- •Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
- •Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
- •History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
结局指标
主要结局
Number of treated bleeds over time
Number of treated bleeds over time
次要结局
- Number of all bleeds over time
- Number of treated spontaneous bleeds over time
- Number of treated joint bleeds over time
- Incidence and severity of adverse events
- Incidence and severity of thromboembolic events
- Incidence and severity of thrombotic microangiopathy events
- Incidence and severity of injection-site reactions
- Incidence of adverse events leading to drug discontinuation
- Incidence of severe hypersensitivity, anaphylaxis, or anaphylactoid reactions
- Changes from baseline in physical examination findings, vital signs, and ECG parameters
- Incidence of laboratory abnormalities
- Trough plasma concentration of emicizumab
- Prevalence and incidence of ADAs to emicizumab
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (14)
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