EUCTR2018-004016-22-GR进行中（未招募）1 期
Safety and acceptability of deferiprone delayed release tablets in patients with systemic iron overload - LA61-0218
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female aged = 18 years
- •Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a regular regimen of red blood cell transfusions
- •On a stable regimen (=3 months) of Ferriprox tablets for the treatment of systemic iron overload
- •A record of at least the last 12 measured ALT and AST levels prior to baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •ALT and/or AST value > 5 x ULN at screening
- •Active case of hepatitis B or C at screening
研究者
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