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临床试验/RBR-57rnpz
RBR-57rnpz招募中未知

Brazilian registry of people with hemophilia A using emicizumab (Emicizumab Cases, EMCase)

niversidade Federal de Minas Gerais0 个研究点开始时间: 2020年3月23日最近更新:

试验速览

阶段
未知
状态
招募中
发起方

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

入选标准

  • Any patient with AH who is going to use or is using MC-Ab may be included in the study, by clarifying and signing the appropriate terms (Free and Informed Consent Form / TALE, for children between 6 and 17 years old; and Term of Free and Informed Consent / ICF, for caregivers responsible for children up to 17 years of age and for patients aged 18 or over), according to Resolution 466, of December 12, 2012, of the National Health Council. service in which the patient is treated must be regularly and ethically registered in the registry, according to the norm of each institution.As patients using the MC-Ab appear, services will be registered through amendments and patients will be included, after signing the appropriate terms (TCLE / TALE). The study will remain open for the capture of new cases for 12 years and each patient will be followed for up to 10 years. The evaluated indicators will be collected at the frequency of each institution, based on the guidelines of the coordinating team. Attention will be paid so that there is at least one evaluation of each indicator before starting to use the MC-Ab.

排除标准

  • complete the 10-year follow-up of the study;
  • discontinue the use of MC-Ab for more than 6 months, for any reason;
  • wish to leave the registry for any reason;
  • evolve to death.

研究者

发起方
niversidade Federal de Minas Gerais

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