NCT00379483已完成2 期
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
研究概览
简要总结
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.
The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox
排除标准
- •Pregnant or breast feeding patients
- •Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
研究组 & 干预措施
Arm 1
Experimental
干预措施: Deferasirox (Drug)
结局指标
主要结局
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
时间窗: at 3, 4, 5 years
次要结局
- Change in liver iron content measured by SQUID, at 3, 4, and 5 years(at 3, 4, 5 years)
研究者
研究点 (1)
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