EUCTR2011-001935-21-IT进行中（未招募）不适用
An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide and related items in blood samples from subjects who previously received taspoglutide and experienced a systemic allergic reactuin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Subjects who, during one of the Roche T-Emerge Programme studies,
- •experienced a serious or non-serious adverse event (AE) that is
- •suggestive of a possible systemic allergic reaction to the study drug (per
- •the Investigator's assessment).
- •- Ability and willingness to give written informed consent and to provide
- •a blood sample for the BAT.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Subjects who participated in any other clinical study within 30 days
- •prior to screening or who may enter another clinical study during the
- •course of this study.
- •Subjects who experienced a systemic allergic reaction, during one of
- •the Roche T-Emerge Programme Studies, more than 24 months prior to
- •Subjects who received immunosuppressants within 1 week prior to
- •Subjects who received any GLP-1 mimetic/analogue other than
- •taspoglutide at any time.
- •Subjects who received taspoglutide since the last administration in
- •the T-Emerge Programme.
研究者
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