NCT02634424终止不适用
Interest of Preventive Personalized Treatment in Hemophilia A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Joint Annual Bleeding Rate
研究概览
简要总结
The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice
详细描述
Starting from 3 pharmacokinetic (PK) points, data are entered in the PK calculator device, and treatment dose is adjusted following the results of PK values obtained and clinical bleeding data
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Patient
- •Severe or moderately severe haemophilia A (FVIII = 2 %), preventively treated (processing) by ADVATE for at least 6 months,
- •At last 6 years old,
- •An informed consent must be signed by the patient or his legal representative for the patients minor.
- •Affiliated to a national insurance scheme
排除标准
- •Previous or actual treatment with FVIII inhibitors > 0,6 UB at the selection
- •Induction of immune tolerance
- •Planned orthopedic surgery for the 18 next months
- •Any other haemostatic pathology
- •Any treatment interacting on the haemostasis
- •Patient under guardianship
- •Patient participating in another biomedical research
结局指标
主要结局
Joint Annual Bleeding Rate
时间窗: during 6 months before (retrospectively) and up to 12 months after using of myPKFiT
Joint Annual Bleeding Rate assessed by usual patient book
次要结局
- Hemorrhagic Risk Sport(up to 6 and 12 months)
- Adherence to treatment estimated as the quantity of Facteur VIII consumed reported to the prescribed quantity.(up to 6 and 12 months)
- Consumption of Factor VIII estimated by the Quantity of Facteur VIII consumed by thr patient.(during 6 months before (retrospectively) and up to 12 months after using of myPKFiT)
- Evolution between the annualized incidence of intercurrent events appeared or worsened under each treatment period (with and without myPKFit), globally, by System Organ ( SO) and Preferred Term ( PT) of the code MedDRA(during 6 months before (retrospectively) and up to 12 months after using of myPKFiT)
- Total annual bleeding rate(during 6 months before (retrospectively) and up to 12 months after using of myPKFiT)
- Quality of life(up to 12 months)
- Joint function(up to 12 months)
研究者
研究点 (2)
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