NCT00093171已完成3 期
An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)
Wyeth is now a wholly owned subsidiary of Pfizer7 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2004年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 7
研究概览
简要总结
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •Hemophilia B (FIX:C less than 2%)
- •Previous treatment of at least 150 exposure days using any FIX product
- •12 years of age and older
排除标准
- •The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
- •Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
- •Patient has a genetic coagulation disorder other than hemophilia B
研究者
研究点 (7)
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