跳至主要内容
临床试验/EUCTR2020-004995-17-NL
EUCTR2020-004995-17-NL进行中(未招募)1 期

ow dose iron chelation as TReatment of Oxidative stress in Sickle cell disease; TROS study - TROS study

AMsterdam UMC-AMC0 个研究点目标入组 30 人开始时间: 2021年3月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
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

  • 1. Sickle cell disease diagnosis: HbSS, or HbSß0-thalassemia genotype
  • 2. Age 18-65 years
  • 3. Willing and able to provide written informed consent
  • 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

排除标准

  • 1. Blood transfusion in the preceding four months
  • 2. Already using iron chelation due to iron overload
  • 3. Ferritin levels of <50 µg/L and/or transferrin saturation of < 0.20.
  • 4. LDH of < 300 U/L
  • 5. Pregnancy or the desire to get pregnant in the following 6 months
  • 6. Impaired renal function of GFR < 60 ml/min/1,73m2 (CKD-EPI).
  • 7. Known allergic reaction to deferasirox.
  • 8. Other somatic or cognitive condition disturbing adherence to study treatment

研究者

发起方
AMsterdam UMC-AMC

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