An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
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
- Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
研究概览
简要总结
To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.
To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety
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
- •Previously treated patients
- •At least 12 years of age
- •Severe Haemophilia B and without inhibitor to factor IX
排除标准
- 未提供
研究组 & 干预措施
Replenine®-VF
干预措施: Replenine®-VF (High Purity Factor IX) (Biological)
结局指标
主要结局
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
时间窗: Baseline and 3 months post-baseline.
Safety assessments included: * assessment of tolerance at injection site * assessment of Factor IX inhibitor development * assessment of frequency and type of adverse event * routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) * screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).
次要结局
未报告次要终点