NCT00563771已完成4 期
Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
适应症
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
- 38
- 试验地点
- 2
- 主要终点
- Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
研究概览
简要总结
To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )
- •With a minimum life expectancy of 3 months
- •Having previously signed a written informed consent.
排除标准
- •Hypersensitivity to uricase or any of the excipients.
- •Known history of G6PD deficiency.
- •Previous treatment with Rasburicase or Uricozyme.
- •Treatment with any investigational drug within 30 days before planned first Rasburicase administration.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
次要结局
未报告次要终点
研究者
研究点 (2)
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