NCT01346215Unknown3 期
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
研究概览
简要总结
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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 research that agree to participate in the study and sign the informed consent form;
- •Patients aged over 18 years, both sexes, regardless of color or social class;
- •Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
- •Patients with laboratory results within specified acceptance criteria.
排除标准
- •Patients who are taking part or took part in another clinical investigational study within 12 months;
- •Hypersensitivity to heparin sodium and/or benzyl alcohol;
- •History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
- •History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
- •Severe liver disease;
- •Patients in cancer treatment;
- •Pregnant and lactating women;
- •Use of glucocorticoids over physiological dose;
- •Use of other anticoagulants;
- •Patients undergoing any surgery performed less than 15 days;
- •History of non response or exacerbated response to heparin sodium;
- •Patients who do not adapt to 150 UI/kg dose.
结局指标
主要结局
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
时间窗: 4 weeks (12 consecutive sessions)
次要结局
- Pharmacodynamic activity of heparin observed through aPTT marker(4 weeks (sessions 1, 6 and 12))
- Safety in use of heparin by monitoring adverse events(5 weeks (12 consecutive sessions + 1 post treatment session))
研究者
研究点 (1)
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