临床试验/NCT01234545

NCT01234545已完成不适用

A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors

Novo Nordisk A/S0 个研究点目标入组 35 人开始时间: 2010年10月最近更新: 2014年11月14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: 35
主要终点: Number of bleeds managed at home

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 trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

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: 2 Years 至 —（Child, Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Patients with congenital haemophilia and inhibitors to factor VIII or IX
•Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

排除标准

•Known or suspected allergy to study product(s) or related products
•Clinically relevant coagulation disorders other than congenital haemophilia A or B

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

Number of bleeds managed at home

时间窗: Month 8

Number of treatments resulting in the control of bleeding episode

时间窗: within 9 hours after the first injection of study product

Number of treatments resulting in effective pain relief

时间窗: within 9 hours after the first injection of study product

次要结局

Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home(Month 8)
Proportion of patients who used their entire treatment at home(Month 8)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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