NCT00837356已完成1 期
A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
研究概览
简要总结
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
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
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe haemophilia A (FVIII level less than or equal to 1%)
- •Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
- •HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
排除标准
- •Presence of any bleeding disorder in addition to haemophilia A
- •Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
- •Abnormal renal function tests
- •Known hypersensitivity to Advate®
研究组 & 干预措施
Advate®/turoctocog alfa
Experimental
干预措施: Advate® (Drug)
Advate®/turoctocog alfa
Experimental
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
时间窗: at 30 days
次要结局
- Inhibitor development(at 30 days)
研究者
研究点 (1)
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