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临床试验/JPRN-jRCT1080223601
JPRN-jRCT1080223601已完成未知

A Multicenter Observational Study Evaluating the Effectiveness of Recombinant Coagulation factor VIII Fc Fusion protein (rFVIIIFc) in Adolescents and Children with Hemophilia under real world clinical setting in Japan

Sanofi K.K.0 个研究点目标入组 160 人开始时间: 2017年7月27日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
Sanofi K.K.
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
>= 至 <= 17age old(—)
性别
All

入选标准

  • Patients with hemophilia A with any severity and treated with rFVIIIFc
  • Detailed criteria are described in the protocol.
  • Patients less than 18 years of age with hemophilia A with any severity and treated with rFVIIIFc. (include over 18 years patients in part 2 study)
  • Part 1 study: general pediatric study
  • Part 2 study: inhibitor positive patient diagnosed by the treating physician

排除标准

  • Candidates will be excluded from study entry if any of the following exclusion criteria exist.
  • 1.Patients to whom Informed consent cannot be conducted or who have no willingness to provide informed consent
  • 2.Those with other bleeding disorder than hemophilia A
  • 3.Patients 18 years of age and older at entry (part 1 study)

研究者

发起方
Sanofi K.K.

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