临床试验/NCT01220141

NCT01220141已完成不适用

Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

Novo Nordisk A/S0 个研究点目标入组 51 人开始时间: 2010年11月最近更新: 2015年4月16日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 51
主要终点: Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory

研究概览研究设计入排标准研究组 & 干预措施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

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: Male
接受健康志愿者: 否

入选标准

•Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
•Treated with room temperature stable NovoSeven®

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)

结局指标

主要结局

Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory

时间窗: after 25 exposure days

次要结局

Adverse events reported as potentially related to activated recombinant human factor VII(after 25 exposure days)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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