跳至主要内容
临床试验/NCT00167973
NCT00167973已完成不适用

A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 218 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
218
主要终点
Observation for safety

研究概览

简要总结

This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

排除标准

  • 未提供

结局指标

主要结局

Observation for safety

时间窗: Study Duration

次要结局

未报告次要终点

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry

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