Efficacy and safety of oral hydroxyurea in transfusion dependent beta-thalassaemia: a randomized double-blind placebo-controlled clinical trial

Faculty of Medicine - University of Kelaniya0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Male and female patients with confirmed genotype of homozygous or compound heterozygous beta-thalassaemia major or HbE beta-thalassaemia
•2. Age above 12 years
•3. Patients who required more than 10 transfusions during the preceding year

•1. Patients who have undergone bone marrow transplantation
•2. Patients with very high serum ferritin (>5000ng/ml)
•3. Sickle beta-thalassaemia
•4. Chronic liver disease
•5. Chronic kidney disease
•6. Patients with contraindications for hydroxyurea therapy (eg: hypersensitivity, severe anaemia with haemoglobin less than 5g/dl at the beginning of treatment, bone marrow depression, pregnancy and lactation)
•7. Patients who are expecting to get pregnant during next 12 months
•8. White blood cell count less than 4000/uL.
•9. Platelet count less than 150,000/uL.
•10. Evidence of active viral infection, including viral hepatitis
•11. Patients on immunosuppressant therapy

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