IRCT2015101218603N2已完成3 期
To assess compliance, efficacy and satisfaction with two different formulation of deferasirox in patients with transfusion-dependent beta-thalassemia
Vice chancellor of research, Shiaz Univeisity of Medical Sciences0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 10 years 至 no limit（—）
- 性别
- All
入选标准
- •signing informed consent; male or female aged = 2 years at screening; patients with transfusion dependent thalassemia major; regular transfusion indicated by a blood requirement = 8 blood transfusions per year at screening. Exclusion criteria: patients with mean levels of ALT above 5 fold the upper limit of normal (ULN); patients with serum creatinine above ULN; significant proteinuria as indicated by a urinary protein/creatinine ratio> 0.6 (mg/mg); creatinine clearance = 60 ml/min; chronic hepatitis B infection; active hepatitis C infection; pregnancy or breastfeeding; non-transfusion dependent thalassemia (NTDT)
排除标准
- 未提供
研究者
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