EUCTR2012-000603-32-NL进行中（未招募）1 期
Proton pump inhibitors in the prevention of iron reaccumulation in patients with hereditary hemochromatosis - He-ppi
Annadalstichting0 个研究点目标入组 56 人开始时间: 2012年8月16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
- 56
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
- •Patient with hereditairy hemochromatosis, homozygous for c282Y currently treated with phlebotomy as maintenance therapy for at least 12 months with >/= phlebotomies per year.
- •Ferritin level between 50-100 ug/l at start of inclusion.
- •Age 18-75 years
- •Weight > 50kg
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients receiving other therapies such as chelating therapy or forced diet
- •Obesitas (BMI > 35)
- •Patients who are mentally incapacitated
- •pregnancy; women expecting / planning to become pregnant during the study period.
- •Patients with a malignancy
- •Patients already on ppi treatment
- •patients experienced side effects ppi.
研究者
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PPI in secondary hemochromatosis.Iron overload (secondary hemochromatosis) in non-transfusion dependent forms of hereditary anemias. Iron overload and hereditary anemia are a growing, underestimated emerging health care problem.MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10057875Term: Secondary haemochromatosisSystem Organ Class: 100000004861MedDRA version: 20.0Level: HLTClassification code 10022979Term: Iron excessSystem Organ Class: 100000004861MedDRA version: 20.0Level: LLTClassification code 10055610Term: HemoglobinopathySystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10074356Term: Non-transfusion dependent thalassemiaSystem Organ Class: 100000004850EUCTR2017-003777-34-NLMC Utrecht40