NCT01335061已完成3 期
A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 34
- 主要终点
- Annualized Number of Bleeding Episodes.
研究概览
简要总结
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented history of moderately-severe to severe hemophilia B (FIX activity </=2%).
- •Male subjects, aged 12 years to 65 years.
- •Subjects with at least 100 exposure days (EDs) to factor IX products.
- •Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.
排除标准
- •Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
- •Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
- •Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
- •Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper limit of normal) of the reporting laboratory.
- •Subjects with a known hypersensitivity to any FIX product or hamster protein.
结局指标
主要结局
Annualized Number of Bleeding Episodes.
时间窗: 2 years
The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.
次要结局
- Average Infusion Dose.(2 years)
- Response to On-Demand Treatment for All Bleeding Episodes.(2 years)
- Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.(2 years)
- Total Factor Consumption.(2 years)
- Incidence of Less Than Expected Therapeutic Effect (LETE)(2 years)
- Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.(2 years)
研究者
研究点 (34)
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