Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Number of patients achieving a response (Platelet count > 30x10^9/L and doubling of the baseline count) or a complete response (platelet count > 100x10^9/L for a t least 6 months)
研究概览
简要总结
Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).
详细描述
Hydroxychloroquine (HCQ) is usually used in Patients with Systemic Lupus Erythematosus (SLE) in order to treat mainly arthralgia or skin manifestations of this disease. A few studies have previously shown that HCQ could also be useful for treating autoimmune cytopenia and particularly autoimmune thrombopenia associated with SLE. In this retrospective study, the investigators have selected patients followed in our center and who have received HCQ either for an authentic SLE or because they had positive antinuclear antibodies (> 1/160e on HEP2 cells) without a definite SLE according to the American College of Rheumatology.
The main goal of this study is to compare the efficacy of HCQ in these two subgroups of patients.
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
- •Patients older than 18 years old
- •Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011
- •Positive antinuclear antibodies > 1/160e on Hep2 cells
排除标准
- •Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)
结局指标
主要结局
Number of patients achieving a response (Platelet count > 30x10^9/L and doubling of the baseline count) or a complete response (platelet count > 100x10^9/L for a t least 6 months)
时间窗: one year
Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment
次要结局
- Tolerance of Hydroxychloroquine(one year)
研究者
Khellaf Mehdi
Principal Investigator
Henri Mondor University Hospital