NCT02516579已完成不适用
ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theravia
- 入组人数
- 1,906
- 试验地点
- 60
- 主要终点
- % of Patient-years With Malignancies
研究概览
简要总结
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
- •With symptomatic sickle cell syndrome
- •Treated with Siklos®
- •Having been informed of the study by the initiating physician and consenting to participate to the cohort.
排除标准
- 未提供
结局指标
主要结局
% of Patient-years With Malignancies
时间窗: During the follow-up of participant, up to 10 years
% of Patient-years With Skin Ulcerations
时间窗: During the follow-up of participant, up to 10 years
Patients with at least one skin ulceration
% of Patient-years With Myelosuppressions
时间窗: During the follow-up of participant, up to 10 years
Patients with at least one myelosuppression
次要结局
未报告次要终点
研究者
研究点 (60)
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