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临床试验/NCT01233258
NCT01233258已完成3 期

A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)

Bayer47 个研究点 分布在 18 个国家目标入组 80 人开始时间: 2011年1月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
Bayer
入组人数
80
试验地点
47
主要终点
Annualized Number of All Bleeds
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • •Male, aged 12 to 65 years
  • •Severe hemophilia A
  • •History of more than 150 exposure days (ED) with clotting factor concentrates
  • •Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
  • •No current Factor VIII inhibitor or history of inhibitor
  • •Willing to use electronic patient diary

排除标准

  • •Presence of another bleeding disease that is different from hemophilia A
  • •Thrombocytopenia
  • •Abnormal renal function
  • •Presence of active liver disease
  • •Known hypersensitivity to FVIII

结局指标

主要结局

Annualized Number of All Bleeds

时间窗: Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)

The annualized number of bleeds experienced by participants

次要结局

  • Annualized Number of All Bleeds During CS/ADJ Period(Up to 6 months (6 months on CS/ADJ potency assignment))
  • Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)(Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design))
  • Annualized Number of All Bleeds During CS/EP Period(Up to 6 months (6 months on CS/EP potency assignment))

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (47)

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