NCT04349306已完成4 期
An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin¿s Lymphoma and Acute Leukemia
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
- 50
- 试验地点
- 1
- 主要终点
- Incidence of AEs and SAEs
研究概览
简要总结
Primary Objective:
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
详细描述
Study duration per participants is approximatively 14 days including a 5-day treatment period.
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
- 2 Years 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
rasburicase
Experimental
rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement
干预措施: RASBURICASE SR29142 (Drug)
结局指标
主要结局
Incidence of AEs and SAEs
时间窗: Day 1 to Day 7
Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
次要结局
- Number of responders after completion of rasburicase treatment under chemotherapy(Day 1 to Day 7)
- Proportion of patients who can maintain the normal uric acid levels throughout the study(Day 1 to Day 7)
- Percentage of the maximum decreasing degree of plasma uric acid level from baseline(Day 1 to Day 7)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy PatientsTumor Lysis SyndromeLymphomaLeukemiaHyperuricemiaNCT00186940St. Jude Children's Research Hospital16
已完成
4 期
Fasturtec TLS Treatment / ProphylysisTumor Lysis SyndromeNCT00651911Sanofi45
已完成
2 期
Rasburicase in Patients at Risk for Tumor Lysis SyndromeTumor Lysis SyndromeNCT00628628M.D. Anderson Cancer Center82
招募中
2 期
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMAThrombotic MicroangiopathiesHematopoietic Stem Cell TransplantationNCT05855083Omeros Corporation18
进行中（未招募）
2 期
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSDNeuromyelitis Optica Spectrum DisorderNCT05346354Alexion Pharmaceuticals, Inc.12