临床试验/NCT00108758

NCT00108758已完成2 期

Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Novo Nordisk A/S38 个研究点分布在 13 个国家目标入组 23 人开始时间: 2004年3月最近更新: 2017年1月12日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 23
试验地点: 38
主要终点: Reduction of bleeds

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 Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B 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

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

•Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

排除标准

•Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

结局指标

主要结局

Reduction of bleeds

时间窗: During 3 months treatment period as compared to 3 months observation period

次要结局

Efficacy variables

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (38)

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