Proton pump inhibition for secondary hemochromatosis in hereditary anemia, a phase III placebo controlled randomized cross-over clinical trial. - PPI in secondary hemochromatosis.

niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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 before study inclusion <7.0 mmol/L
•o Clinically stable and relevant iron overload defined as either one of:
•- 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.
•- 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 Received less than 10 units of blood during the preceding 12 months.
•o Is expected to receive less than 4 units fo blood during the following 12 months
•o Is not splenectomized during the preceding 24 months.

•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.

发起方

niversitair Medisch Centrum Utrecht