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
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