临床试验/NCT00853086

NCT00853086已完成不适用

United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 139 人开始时间: 2008年1月最近更新: 2016年11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: 139
试验地点: 1
主要终点: Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes.

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研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

详细描述

Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

性别: Male
接受健康志愿者: 否

入选标准

•All haemophilia A or B patients with inhibitors treated with NovoSeven are included

排除标准

•No exclusion criteria beyond the contraindications described in the approved product information text

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

Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes.

时间窗: Assessments at 6 month intervals

次要结局

未报告次要终点

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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