French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Exposition or non exposition to available immune thrombocytopenia persistent
研究概览
简要总结
Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Incident case of immune thrombocytopenia or control patient
排除标准
- •Patient not registered in the database between 2009 and 2012
结局指标
主要结局
Exposition or non exposition to available immune thrombocytopenia persistent
时间窗: up to 10 years
Data will be extracted until the end of study
次要结局
- Mortality as assessed date of death collected in the database(Each year until 10 years)
- Number of hospitalization for bleeding in the database(Each year until 10 years)
- Safety of treatment for cardio-vascular events(Each year until 10 years)
- Safety of treatment for thrombo-embolic events(Each year until 10 years)
- Safety of treatment for infections(Each year until 10 years)