NL-OMON25811已完成不适用
Proton pump inhibition for secondary hemochromatosis in hereditary anemia, a phase III placebo controlled randomized cross-over clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
入选标准
- •o diagnosis of hereditary anemia: hemoglobinopathy (including all sickle cell syndromes and beta-thalassemia), sideroblastic anemia, congenital dyserythropoietic anemia or an erythrocyte enzyme deficiency.
- •o hemoglobin level before study inclusion <7.0 mmol/L.
- •o clinically stable and relevant iron overload defined as either one of:
- •o a baseline LIC measurement by MRI between 3 and 15 mg Fe/g without having received iron chelation 2 months prior to entering the study.
- •o OR a baseline LIC measurement by MRI between 3 and 15 mg Fe/g on stable chelation therapy (deferasirox, deferoxamine or deferiprone), with documented stable dosage the preceding 2 months and no expected dose reductions or increases the next two years.
- •o aged more than 18 years and able to sign informed consent.
- •o serum transferrin saturation higher than 0.40 once during the preceding 24 months.
- •o received less than 10 units of blood during the preceding 12 months.
- •o is expected to receive less than 4 units of blood during the following 12 months
- •o is not splenectomized during the preceding 24 months.
排除标准
- •o Pregnancy.
- •o Liver cirrhosis.
- •o Heart failure.
- •o Severe cardiac iron overload defined as MRI T2* < 20 ms.
- •o Severe liver iron overload defined as MRI LIC > 15 mg Fe/g dw.
- •o Expected poor compliance.
- •o Currently taking PPI and not able to stop for personal or medical reasons.
- •o Patients that are being phlebotomized as treatment for iron overload.
- •o Current peptic ulcer disease, gastro-intestinal bleeding or other causes of blood loss.
- •o Contra-indication for esomeprazole use.
- •o Concomitant use of clopidogrel.
- •o Contra-indication for MRI.
- •o Received more than 4 units blood during one of the treatment periods of 12 months.
研究者
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