跳至主要内容
临床试验/EUCTR2005-001426-84-FR
EUCTR2005-001426-84-FR进行中(未招募)1 期

Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14

OCTAPHARMA AG0 个研究点目标入组 17 人开始时间: 2006年10月23日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
OCTAPHARMA AG
入组人数
17

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

性别
All

入选标准

  • Patients<6 years of age at study admission;
  • Defined inherited VWD of any type;
  • DDAVP treatment known or suspected to be inadequate, insufficient or contraindicated;
  • an expected minimum of 5 exposure days to WILATE within 1 year of observation
  • HIV-1/2 negative
  • Freely given fully informed conset has been obtained from the patient's parents
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • any haematological disorder other than VWD
  • diagnosis of aquired VWD
  • any known present or past inhibitor activity against VWF or FVIII
  • administration of DDAVP or other blood/plasma products 5 days prior to the 1st WILATE injection
  • administration of acetylsalicylic acid 14 days before treatment with WILATE
  • known history of intolerance towards plasma derived or blood products
  • participation in another clinical study currently or during the past four weeks

研究者

发起方
OCTAPHARMA AG

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