NCT01369719已完成不适用
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
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
- 138
- 试验地点
- 1
- 主要终点
- Ferritin level
研究概览
简要总结
Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.
详细描述
This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.
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
- Double (Participant, Investigator)
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
- •Confirmed intermedia or major thalassemia
- •More then 2 years old
- •Serum Ferritin level > 1000
- •Normal Creatinine and Complete Blood Count (CBC)
排除标准
- •HCV, HBV or HIV positive patients
研究组 & 干预措施
Osveral
Experimental
20 mg/kg oral osveral daily
干预措施: osveral (Drug)
desferal
Active Comparator
40mg/kg desferal for 6 nights in a week subcutaneously
干预措施: Desferal (Drug)
结局指标
主要结局
Ferritin level
时间窗: 8 months
ferritin level in months 4 and 8 of the study
次要结局
- Hemoglobin level(8 month)
- Drug side effects(8 months)
研究者
研究点 (1)
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