NCT01138501已完成3 期
A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
研究概览
简要总结
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
- •Age below 12 years and weight at least 11 kg
排除标准
- •Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
- •Congenital or acquired coagulation disorders other than haemophilia A
- •Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
研究组 & 干预措施
rFVIII
Experimental
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
时间窗: The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
次要结局
- Frequency of Adverse Events (AEs)(The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject)
研究者
研究点 (1)
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