NCT00069862已完成1 期
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2003年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- safety and tolerability
研究概览
简要总结
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
- •No clinically significant findings on physical exam, medical history, or screening laboratories.
- •Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm
- •Willing and able to discontinue DFO or L1 for the period of study.
- •Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
- •Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.
排除标准
- •Serious medical condition unrelated to Beta-Thalassemia.
- •Participation in a previous investigational drug study within 30 days preceding screening.
- •Patients with a known allergy to DFO that prevents chronic administration.
结局指标
主要结局
safety and tolerability
iron excretion in urine and stool
pharmacokinetic measurements
次要结局
未报告次要终点
研究者
研究点 (1)
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