临床试验/NCT01874405

NCT01874405已完成不适用

Effectiveness of Deferasirox Therapy on Comprehensive Management of Iron Overload in Adult and Pediatric Transfusion-dependent Patients: a Long Term Retrospective Study

University of Campania "Luigi Vanvitelli"0 个研究点目标入组 80 人开始时间: 2003年3月最近更新: 2013年6月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Campania "Luigi Vanvitelli"
入组人数: 80
主要终点: cardiac T2* in patients treated with deferasirox

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Iron overload is a leading cause of morbidity and mortality in transfusion-dependent patients. Deferasirox is the most promising iron chelator agent in several clinical scenarios. The investigators propose a retrospective study (chart review) to evaluate comprehensive iron overload management in transfusion-dependent patients treated with deferasirox for up to 5-10 years in a real clinical practice setting.

研究设计

研究类型: Observational
观察模型: Case Only
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: 否

入选标准

•Transfusion- dependent patients (> 2 years);
•Ongoing deferasirox therapy during the study period;
•≥ 2 Magnetic Resonance scans (one at baseline and at least one post baseline - as per clinical need) during study period (this criteria is not mandatory for patients undergoing only the endocrine subanalysis and participating only to the cardiac analysis);
•Available medical history including relevant clinical and laboratory data (e.g serum ferritin, liver function tests, renal function tests, endocrine parameters ) at baseline before starting deferasirox treatment

排除标准

•Non transfusion- dependent patients;
•Other chelation therapy than deferasirox;
•Absence of complete medical history as above specified

结局指标

主要结局

cardiac T2* in patients treated with deferasirox

时间窗: at least 1 year

maintenance from baseline to end of study of cardiac T2\* in not iron overloaded patients (cardiac T2\* \>20 ms at baseline)

次要结局

cardiac function in patient undergoing deferasirox treatment(at least 1 year)
change in liver iron concentration(at least 1 year)
maintenance of normal endocrine function in patients without endocrine dysfunction and improvement in disease severity in patients affected by endocrine dysfunction from baseline to end of study(at least 3 years)

研究者

发起方

University of Campania "Luigi Vanvitelli"

申办方类型

Other

责任方

Principal Investigator

主要研究者

Silverio Perrotta

University of Campania "Luigi Vanvitelli"

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