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临床试验/NL-OMON32149
NL-OMON32149撤回4 期

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with Raptiva (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST). - CLEAREST-TRAI

Serono0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Subject participating to Study 25878 currently treated or having been treated with efalizumab, with the last dose received within 6 weeks before inclusion in this trial.
  • - Subject developing during the study 25878 either:
  • * a newly diagnosed autoimmune disease (suspected or confirmed)
  • * a severe thrombocytopenia defined as grade III or IV according to NCI-CTCAE cirteria
  • - subject is willing and able to participate in the trial and has provided signed, informed consent.;For subjects of control group:
  • - subject is either currently treated with efalizumab or not (i.e. last dose of efalizumab received more than 6 weeks before study entry)

排除标准

  • - Participation to any interventional clinical study (inclusion in other registry/observational study is possible).
  • - Administration of specific treatment for the current thrombocytopenia before inclusion in the study.

研究者

发起方
Serono

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