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临床试验/EUCTR2014-001362-10-Outside-EU/EEA
EUCTR2014-001362-10-Outside-EU/EEA进行中(未招募)不适用

Routine prophylaxis treatment versus On-demand treatment for Children with severe Hemophilia A: comparison of all bleeding events in Chinese Hemophilia patients

Bayer HealthCare AG0 个研究点目标入组 35 人开始时间: 2014年11月4日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
35

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
Male

入选标准

  • Inclusion Criteria: - Male, aged 2-16yrs - Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] ) - Minimum of at least 50 documented ED (exposure day) prior to enrolment - No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation - Parents or legal guardians document, sign, and date informed consent
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 35
  • 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

  • Exclusion Criteria: - Another bleeding disease that is different from hemophilia A - Known hypersensitivity to the active substance, mouse or hamster protein - Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records

研究者

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