A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen

Bayer0 个研究点目标入组 38 人开始时间: 2007年12月最近更新: 2014年11月2日

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: 38
主要终点: To evaluate the frequency of all bleeds (spontaneous and trauma) during the study

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

年龄范围: 14 Years 至 29 Years（Child, Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Severe hemophilia A (<2%)
•For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
•For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
•For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
•Current treatment with rFVIII

排除标准

•Other known hematological / bleeding disorders other than hemophilia A
•Participating on another study that may have an impact on bleeding or the objectives of this study
•Known alcohol and drug abuse

结局指标

主要结局

To evaluate the frequency of all bleeds (spontaneous and trauma) during the study

时间窗: End of Study

次要结局

To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy(End of Study)
To evaluate the change from baseline in HRQoL (health-related quality of life)(End of Study)
To evaluate the change from baseline in the Gilbert score(End of Study)
To evaluate the number of target joint development(End of Study)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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