NCT01053715已完成不适用
A European, Prospective, Non-Interventional Study to Assess Health Related Quality of Life and to Identify Key Transitional Life Events in Patients With Moderate or Severe Haemophilia A Using Helixate NexGen
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
- 78
- 试验地点
- 31
- 主要终点
- Health Related Quality of Life (HRQoL)
研究概览
简要总结
The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.
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 35 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Haemophilia A patient
- •Severely (<1%) and moderately (1-5%) affected
- •On treatment with Helixate NexGen
- •Ability to read and understand study materials (patient information and data protection form, patient-related questionnaires)
- •Signed data protection form; if patient is <18 years of age, legal guardian must also give written consent by signing the data protection form
排除标准
- •Presence of inhibitors
- •Abuse of recreational drugs or alcohol interfering with the every-day-life in the opinion of the physician
- •Advanced stage human immunodeficiency virus (HIV) infection (CD4 cell counts <200/cmm, multi-drug resistance, presence of AIDS related signs or symptoms)
- •Symptomatic liver disease (cirrhosis, ascites, esophageal varices)
- •Concomitant or planned interferon therapy
- •Malignancies on or off treatment
结局指标
主要结局
Health Related Quality of Life (HRQoL)
时间窗: baseline and every 12 months over 3 years
次要结局
- Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia(Duration of the study)
- Change in HRQoL due to transitional life events(Duration of the study)
研究者
研究点 (31)
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