Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.
研究概览
简要总结
To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.
详细描述
Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX < 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")*.
* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.
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
- •Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
- •HIV seropositive ( asymptomatic) or seronegative subjects.
- •No history or detectable inhibitors.
排除标准
- 未提供
研究组 & 干预措施
1
Patients will receive Benefix IV according to blood amount
干预措施: Recombinant Factor IX Coagulation (Drug)
结局指标
主要结局
The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.
时间窗: 9 months
次要结局
- The secondary variables will be hemostasis and blood loss during and after surgery.(9 months)