跳至主要内容
临床试验/NCT01394029
NCT01394029已完成不适用

International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年7月最近更新:
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
120
试验地点
1
主要终点
Adverse Drug Reactions

研究概览

简要总结

This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.

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
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
  • (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

排除标准

  • Patients with non-transfusional hemosiderosis
  • Patients treated with deferasirox in an interventional clinical trial
  • Other protocol-defined inclusion/exclusion criteria may apply.

研究组 & 干预措施

deferasirox

干预措施: deferasirox (Drug)

结局指标

主要结局

Adverse Drug Reactions

时间窗: 3 years

Observed over 3 years for each patient

Serum Creatinine and liver enzyme levels

时间窗: 3 years

Observed over 3 years for each patient

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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