NCT00302653已完成4 期
Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
研究概览
简要总结
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
干预措施: Rasburicase (Drug)
结局指标
主要结局
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
时间窗: 28 (+- 3) days after the last dose of rasburicase
Adverse events occurrence
时间窗: During the study
次要结局
未报告次要终点
研究者
研究点 (1)
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