Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Rate of efficacy after switching from one TPO mimetics to a second one.
研究概览
简要总结
TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.
详细描述
Thrombopoietin mimetics agents are available since 5 years in France through clinical trials first and then after their license. Two drugs are used: romiplostim and eltrombopag. These molecules have the same receptor on the megacaryocyte and induce the same stimulation of this cell leading to the differentiation and the proliferation into platelets. But romiplostim and eltrombopag have 2 different characteristics: the way of administration (oral for eltrombopag and subcutaneous for romiplostim) and the binding site to the C-MPL receptor on megacaryocyte. The aim of this study is to describe ITP patients who received these two drugs alternatively in order to know if there is a benefit for switching these molecules in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (Rodeghiero et al, 2009).
- •Subject is equal to or greater than 18 years of age.
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •Subject receiving romiplostim and eltrombopag alternatively
- •Available follow-up of 2 months at least for each period
排除标准
- •Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia
结局指标
主要结局
Rate of efficacy after switching from one TPO mimetics to a second one.
时间窗: 2 months minimun
The primary outcome of this study is to know if switching from one TPO mimetics to a second one in ITP patients lead to a better efficacy in a significative proportion of patients.
次要结局
- Rate of patients with an adverse events who have a benefit after switching.(6 months)
研究者
Khellaf Mehdi
Medical Doctor
Henri Mondor University Hospital