NCT01034904已完成不适用
A Prospective Non-Interventional Study to Describe Health Related Quality of Life of Youth and Young Adults With Moderate or Severe Hemophilia A Using Recombinant Factor VIII (Helixate FS).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Health Related Quality of Life (HRQoL)
研究概览
简要总结
The relevance of the study will be in establishing whether Health Related Quality of Life (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances related to the transition from youth to adulthood. This may support the future use of HRQoL measures as part of routine care in order to identify important changes that are not detectible by other clinical means.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe Hemophilia A (factor level ≤5%)
- •Receiving Helixate FS as on-demand treatment or prophylaxis therapy at time of informed consent
- •Patient age 14 to 29 years at the time of recruitment
- •Complete informed consent process and documentation; (Patients under age 18 must assent in addition to consent of legal guardian)
- •Willing/able to follow study protocol, including keeping a bleeding and treatment diary
- •Able to communicate clearly in either English or French - both written and verbal communication is essential.
排除标准
- •Known inhibitor at time of recruitment (> 0,5 Bethesda units) or immune tolerance therapy at time of recruitment
- •HIV positive
- •Symptomatic Hepatitis B or C infection or active treatment for hepatitis B or C
- •Inability to comply with study protocol
- •Hypersensitivity to Helixate FS or to any ingredients in the formulation or component of the container
- •Hypersensitivity to mouse or hamster protein
- •Unsuitable to participate in study for any other reason as assessed by investigator
结局指标
主要结局
Health Related Quality of Life (HRQoL)
时间窗: Every 6 months over 2 to 3 years
次要结局
- Sensitivity of HRQoL measures to significant life events(3 years)
研究者
研究点 (2)
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