NCT00651911已完成4 期
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for 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
- 45
- 试验地点
- 2
- 主要终点
- To assess the uricolytic response to rasburicase treatment
研究概览
简要总结
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy planned for at least 3 cycles
- •Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
- •With a minimum life expectancy of 3 months
- •Uric acid > 8 mg%
- •Negative pregnancy test < or =to 2 weeks and efficient contraceptive method.
- •Negative HIV serology < or =to 4 weeks
- •Patient or legal guardian has signed a written informed consent
排除标准
- •Hypersensitivity to uricases or any of the excipients
- •Known history of G6PD deficiency.
- •Previous treatment with Rasburicase or Uricozyme®
- •Pregnancy or lactation
- •Treatment with any investigational drug within 30 days before planned first Rasburicase administration
结局指标
主要结局
To assess the uricolytic response to rasburicase treatment
时间窗: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
次要结局
- To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome(5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection))
研究者
研究点 (2)
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