NCT02263456已完成3 期
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
Bio Products Laboratory7 个研究点 分布在 1 个国家开始时间: 1997年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 7
- 主要终点
- Area under the concentration/time curve (AUC) for plasma Factor IX
研究概览
简要总结
The purpose of this study is:
- to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
- to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
- to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 years or over
- •At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product
排除标准
- 未提供
研究组 & 干预措施
Replenine®-VF
Experimental
干预措施: Replenine®-VF (High Purity Factor IX) (Biological)
Current Factor IX
Active Comparator
干预措施: Replenine®-VF (High Purity Factor IX) (Biological)
结局指标
主要结局
Area under the concentration/time curve (AUC) for plasma Factor IX
时间窗: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose
次要结局
未报告次要终点
研究者
研究点 (7)
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