NCT04515680已完成不适用
National Survey on Endocrine Function and Bone Metabolism in Transfusion--dependent Patients Treated With Deferasirox
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Change from baseline number of endocrine disorders at study completion
研究概览
简要总结
A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult and pediatric patients with transfusion---dependent thalassemia;
- •Chelation with deferasirox as assigned chelation therapy;
- •Available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g TSH, FT3 and FT4, fasting serum glucose, OGTT serum glucose, bone mineral density z---score, T---score, g/cm2, PTH, FSH, LH, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, MRI T2* value) at baseline and at the end of study
排除标准
- •Non transfusion- dependent patients;
- •Other chelation therapy than deferasirox or combination with other chelators during the observation;
- •Absence of complete medical history as above specified
结局指标
主要结局
Change from baseline number of endocrine disorders at study completion
时间窗: baseline through study completion, a minimum of 5 years
Absolute change in number of patients diagnosed with any endocrine disorder at the baseline and at the study completion
次要结局
未报告次要终点
研究者
Silverio Perrotta
Prof.
University of Campania "Luigi Vanvitelli"
研究点 (1)
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