Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Mean Serum Ferritin Levels
研究概览
简要总结
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
- •Iron overload (serum ferritin level above 1000 µg/L)
排除标准
- •Patients with other transfusion-dependent anemias
- •Thalassemia major with cardiomyopathy or arrhythmia.
- •Chronic renal failure
- •Chronic liver disease (ALT >200 IU)
- •Hhypersensitivity to deferasirox or desferrioxamine
- •Patients already on combined chelation therapy
研究组 & 干预措施
Deferasirox (DFX) group
DFX group (n=71) included children who used oral (tablet) DFX at a dose of 30 mg/kg once daily for a duration of 6 months.
干预措施: Deferasirox (DFX) (Drug)
Desferioxamine (DFO) group
DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week
干预措施: Deferoxamine (DFO) (Drug)
结局指标
主要结局
Mean Serum Ferritin Levels
时间窗: 6 months
Change in mean serum ferritin level from baseline for each group.
次要结局
未报告次要终点