NCT00631579已完成2 期
Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
研究概览
简要总结
The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.
Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from:
- •acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
- •lymphoma,Stage ≥ III without regard to uric acid level; or
- •lymphomas, Stage II with bulky disease; or
- •lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).
排除标准
- 未提供
结局指标
主要结局
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
次要结局
- Pharmacokinetic parameters and anti-SR29142 antibodies
研究者
研究点 (1)
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