NCT00466063已完成不适用
A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 23
- 主要终点
- Safety - renal and hepatic function monitoring.
研究概览
简要总结
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of transfusion-dependent anemia.
- •History of iron overload
排除标准
- •Patients with non-transfusional hemosiderosis.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
ICL670
ICL670
干预措施: Deferasirox (Drug)
结局指标
主要结局
Safety - renal and hepatic function monitoring.
时间窗: 5 years
次要结局
- Longitudinal ferritin levels(5 years)
- Adverse events(5 years)
- Assessment of auditory and ophthalmologic status(5 years)
研究者
研究点 (23)
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