ISRCTN52984371已完成不适用
A single-centre, prospective, randomised, phase III clinical study to evaluate the efficacy and safety indicators of two different iron chelators in patients with iron overload
Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)0 个研究点目标入组 32 人开始时间: 2011年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Diagnosis of myelodysplastic syndrome
- •3. Have received a hematopoietic stem cell transplantation in the last 6 months
- •4. Gaucher's disease diagnosis
- •5. Serum ferritin concentration >500 mcg/L
- •6. To not have received previous iron chelation therapy
- •7. No severe renal failure (creatinine clearance >30 ml/min/1.73 m2)
- •8. No severe liver failure (liver enzymes under twice the upper normal limit)
- •9. Life expectancy of at least 6 months
排除标准
- •1. To not accept to use reliable contraception throughout the study and during three months after cessation of treatment
- •2. Pregnancy or breast-feeding
- •3. History of cataracts or increasing risk of cataract formation
- •4. Severe renal failure (creatinine clearance <30 ml/min/1.73 m2)
- •5. Active chronic disease such as human immunodeficiency virus (HIV) or hepatitis B or C
- •6. To have received treatment with iron chelators in the last 6 months
- •7. Suspected or known hypersensitivity to the drug under study or any of the excipients
- •8. Dependence or current abuse of drugs or alcohol
- •9. Treatment with another investigational product in the last 6 months prior to baseline
研究者
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