NCT00927667已完成4 期
A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 156
- 试验地点
- 15
- 主要终点
- Maximum ankle MRI score
研究概览
简要总结
The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 12 - 35 years
- •Severe hemophilia A ( < 1 % FVIII:C)
- •No history of Factor VIII inhibitory antibody
- •For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
- •Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
- •Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
- •For the on-demand subjects > 12 bleeds/year in the last 5 years.
- •Written informed consent by subject and parent/legal representative, if < 18 years
排除标准
- •Individuals with other coagulopathies (e.g., von Willebrand disease)
- •HIV seropositive subjects
- •Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
- •HCV seropositive individuals who underwent interferon therapy during the last 12 months
- •Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
- •Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period
- •Joint replacement
- •For the on-demand treatment group, any period greater than 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding
结局指标
主要结局
Maximum ankle MRI score
时间窗: no timeframe (single visit, "snapshot" of the actual joint status)
次要结局
- Total MRI score of the maximum index joint(no timeframe (single visit, "snapshot" of the actual joint status))
- Number of bleeds in each index joint over previous 5 years(no timeframe (medical history status))
- Number of total joint bleeds and their locations over previous 5 years(no timeframe (medical history status))
- Physical joint score (Gilbert Score)(no timeframe (single visit, "snapshot" of the actual joint status))
研究者
研究点 (15)
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