EUCTR2016-001561-88-Outside-EU/EEA进行中（未招募）不适用
A Phase II, Multi-center, Single-arm, Prospective Study to Evaluate the Safety and Efficacy of Deferasirox in Beta-thalassemia Major Patients After Hematopoietic Stem Cell Transplantation
ovartis Pharmaceuticals0 个研究点目标入组 27 人开始时间: 2016年4月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
- •Inclusion Criteria
- •Patients who had HSCT for beta-thalassemia major
- •HSCT was performed minimum 6 months and maximum 2 years ago
- •The washout period after the immunosuppressive therapy should be at least 3 months.
- •Signifacant IOL should be present including:
- •A. Serum ferritin >1000 µg/L or B. cardiac MRI <20 ms or C. liver iron concentration = 5 mg/g dry weight measured by R2* MRI
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 27
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion Criteria
- •Patients who have any contraindication for treatment with deferasirox according to the prescribing information
- •Patients who depend on transfusion
- •Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
- •Patients who are experiencing severe complication of HSCT (e.g. acute GVHD)
- •Significant proteinuria / Increase in serum creatinine
研究者
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