NCT02284789已完成不适用
Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Colorado Adult Joint Assessment Score (CAJAS)
研究概览
简要总结
To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 18 to 50 years of age
- •Diagnosis of moderate to severe hemophilia A (documented <1-2% Factor VIII Concentration [FVIII:C])
- •Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study
排除标准
- •Routine need for wheelchair or routine need for two canes or crutches
- •Diagnosis of another bleeding disorder such as von Willebrand Disease
- •Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)
结局指标
主要结局
Colorado Adult Joint Assessment Score (CAJAS)
时间窗: Up to 25 days
次要结局
未报告次要终点
研究者
研究点 (4)
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