Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Number of bleeding episodes (efficacy after administration)
研究概览
简要总结
In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.
详细描述
The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
- •Above the age of six, at the moment of inclusion
- •Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
- •Informed consent signed by the patients or his legally accepted representative
排除标准
- •Under the age of six, at the moment of inclusion
- •Tested negative for HAV and HBV antibodies
研究组 & 干预措施
A
The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient
干预措施: human coagulation Factor IX (Drug)
结局指标
主要结局
Number of bleeding episodes (efficacy after administration)
时间窗: 24 months
Haematological variables and clinical chemistry (safety)
时间窗: 24 months
Adverse events (safety)
时间窗: 24 months
次要结局
- Occurrence of antibodies to factor IX(24 months)