NCT00710619已完成不适用
Dosing Observational Study in Hemophilia Subjects With Inhibitors: A Phase IV Diary Study in Subjects Prescribed NovoSeven® as First Line on Demand Therapy for Acute Bleeding Episodes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Characterisation of dose and dosing intervals for each bleeding episode
研究概览
简要总结
This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
- •Subjects prescribed NovoSeven® as the first line or recommended bypass agent
- •History of on average at least 4 bleeds of any type over a 3 month period
- •Subject or caregiver able and willing to complete daily journal for 3 months
- •Informed consent obtained from all subjects or legal representative
排除标准
- 未提供
研究组 & 干预措施
A
干预措施: activated recombinant human factor VII (Drug)
A
干预措施: Feiba VH (Drug)
结局指标
主要结局
Characterisation of dose and dosing intervals for each bleeding episode
时间窗: after 3-6 months
次要结局
- Effect of type of bleed on initial dose, dosing interval and total dose(after 3-6 months)
- Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution(after 3-6 months)
- Effect of time to first dose on dosing interval and total dose(after 3-6 months)
- Effect of bleeds and drug administration time on planned daily activities(after 3-6 months)
- Relationship of dose and dosing intervals to reported SAEs(after 3-6 months)
研究者
研究点 (1)
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