EUCTR2011-006294-26-BE进行中（未招募）不适用
A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI (rFVIIa BI) in the Treatment of Acute Bleeding Episodes per an On-Demand Regimen in Patients with Hemophilia A or B with Inhibitors - rFVIIa BI Treatment of Acute Bleeding Episodes per an On-Demand Regimen
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Subject is male with hemophilia A or B with inhibitors, with a high titer (=5 BU) or a historical high anamnestic response.
- •Subject is 12 to 65 years old at the time of screening.
- •Subject is currently using or has used bypassing agents for treatment of bleeding episodes.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 7
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has a known hypersensitivity to rFVIIa, hamster or murine
- •proteins, or Tween 80.
- •Subject has a prior history of thromboembolic event
- •Subject is positive for a FVII inhibitor at screening
研究者
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A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI in the Treatment of Acute Bleeding Episodes per an On-demand Regimen in Patients with Hemophilia A or B with InhibitorsHemophilia A or B with FVIII or FIX inhibitorsMedDRA version: 14.1Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850MedDRA version: 14.1Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850EUCTR2011-006294-26-PLBaxter Innovations GmbH50
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