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临床试验/jRCT1011220023
jRCT1011220023招募中不适用

A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability (IMPACT study)

Sapporo Medical University Hospital0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
招募中
入组人数
1,000
主要终点
-
研究概览入排标准结局指标研究者记录与标识符相似试验

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
No limit 至 No limit（—）
性别
All

入选标准

  • •Subjects whose medical care and prognostic information can be obtained from medical records

排除标准

  • •Subjects presenting with any of the following will be excluded from the study:
  • •Subjects who requested non-participation in this study based on a published opt-out document.
  • •Subjects who are participating in or interested in participating in other clinical trials during the study period.
  • •Subjects who are judged as not suitable for participating in this study by treating physician.

结局指标

主要结局

-

The rate of anti-drug antibody (ADA) development

次要结局

  • Serum chemokine (CXCL12 etc.) protein levels
  • Duration of response
  • The titer of ADA
  • The time to first development of ADA/NAb after start of treatment
  • The presence of neutralizing antibody (NAb)
  • Serum drug concentrations
  • The incidence of infusion reactions
  • The incidence of genetic polymorphisms (CXCL12, FCGRT, HLA etc.)

研究者

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