NCT01179620已完成3 期
A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 109
- 试验地点
- 9
- 主要终点
- Number of patients requiring uptitration
研究概览
简要总结
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients requiring hemodialysis
- •Patients requiring anticoagulation therapy during hemodialysis
- •Written informed consent
排除标准
- •Hypersensitivity to study medication
- •Genetic abnormality or disease of clotting system
- •Prior major surgery or bleeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Certoparin
Experimental
干预措施: Certoparin (Drug)
结局指标
主要结局
Number of patients requiring uptitration
时间窗: Week 8
次要结局
- Pharmacokinetics of Certoparin(Day 1, Week 4)
- Safety and tolerability of Certoparin(8 weeks)
研究者
研究点 (9)
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