Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vit C to Augment iron chelation
研究概览
简要总结
role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
详细描述
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subjects with overload secondary to thalassemia major
排除标准
- •• with HIV positive or have active HCV.
- •A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
- •Participation in a previous investigational drug study within the 30 days preceding screening.
- •A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
- •An inability to adhere to the designated procedures and restrictions of this protocol.
研究组 & 干预措施
vitamin c
25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.
干预措施: Vitamin C, Defriprone, deferisarox (Drug)
iron chelator
Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.
干预措施: deferiprone , deferesarox (Drug)
结局指标
主要结局
Vit C to Augment iron chelation
时间窗: 12 months
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
vitamin c augmenting effect of iron chelator
时间窗: 12 month
better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c
次要结局
- adverse related events(12 month)
研究者
Mohsen Saleh Elalfy
professor
Ain Shams University