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临床试验/EUCTR2018-004891-36-ES
EUCTR2018-004891-36-ES进行中(未招募)1 期

Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors - explorer8

ovo Nordisk A/S0 个研究点目标入组 150 人开始时间: 2019年8月9日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • - Male aged 12 years or older at the time of signing informed consent.
  • - Congenital severe haemophilia A (FVIII less than 1%) or B (FIX 2% or less)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 35
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 105
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - Known or suspected hypersensitivity to monoclonal antibodies
  • - Known inherited or acquired coagulation disorder other than congenital haemophilia
  • - Presence of confirmed inhibitors 0.6 BU or greater at screening

研究者

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