NCT00623727终止2 期
Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 143
- 试验地点
- 97
- 主要终点
- Percentage of Participants With Less Than 9 Total Bleeds Per Year
研究概览
简要总结
A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 12 to 70 years
- •Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
- •Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
- •Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
- •Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
- •Subjects with no measurable inhibitor activity
- •Subjects with no history of FVIII inhibitor antibody formation
- •Written informed consent by subject and parent / legal representative, if < 18 years
排除标准
- •Subjects who are receiving primary prophylaxis
- •Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
- •Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
- •Subjects with abnormal renal function
- •Subjects with elevated hepatic transaminases
- •Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
- •Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
- •Subjects who require any pre-medication for FVIII injections
结局指标
主要结局
Percentage of Participants With Less Than 9 Total Bleeds Per Year
时间窗: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.
次要结局
- Percentage of Participants With Less Than 5 Joint Bleeds Per Year(up to one year)
- Number of Joint Bleeds Per Participant Per Year in Responders(up to one year)
研究者
研究点 (97)
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