rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Novo Nordisk A/S19 个研究点分布在 7 个国家目标入组 24 人开始时间: 2002年11月最近更新: 2017年1月12日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 24
试验地点: 19
主要终点: Global treatment response of the patient by an algorithm based pain and joint mobility assessments

研究概览研究设计入排标准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 trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

性别: Male
接受健康志愿者: 否

入选标准

•Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
•A history of 3 or more joint bleeds during the last 12 months

排除标准

•Joint bleeding within 7 days prior to trial start
•Treatment for bleeds within the last 5 days prior to trial start
•Clinically relevant coagulation disorders other than congenital haemophilia A or B

结局指标

主要结局

Global treatment response of the patient by an algorithm based pain and joint mobility assessments

次要结局

Circumference of joint
Pain assessment
Mobility assessment
Adverse events

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (19)

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