EUCTR2014-005287-15-DE进行中（未招募）1 期
PRE-POINT-EARLY STUDY - Pilot study using oral insulin at early age for immune efficacy in primary prevention of type 1 diabetes - Pre-POINT Early Study
Technische Universität München, Fakultät für Medizin0 个研究点目标入组 44 人开始时间: 2015年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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
入选标准
- •1. Children aged 6 months to 2 years who have a first degree relative with type 1 diabetes, and have a HLA genotype that includes a HLA DR4-DQB1*0302 or HLA DR4-DQB1*0304 haplotype, and does not include one of the following alleles or haplotypes: DR 11, DR 12, DQB1*0602, DR7-DQB1*0303, DR14-DQB1*0503
- •and must be
- •2. Islet autoantibody negative at time of recruitment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Concomitant disease or treatment, which may interfere with assessment or cause immunosuppression, as judged by the investigators.
- •2.Prior or current participation in another intervention trial.
- •3.Any condition that could be associated with poor compliance.
研究者
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