Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 21
- 主要终点
- Number of ITP patients who receive Fostamatinib
研究概览
简要总结
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
详细描述
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
- •Age greater or equal to 18 years at the treatment start
- •Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws
排除标准
- •Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
- •Patients participating in an interventional clinical trial at the time of enrollment.
研究组 & 干预措施
Study group
All patients being observed during the study duration.
干预措施: Fostamatinib (Drug)
结局指标
主要结局
Number of ITP patients who receive Fostamatinib
时间窗: 6 months
effectiveness evaluation of fostamatinib
次要结局
未报告次要终点