EUCTR2005-001621-29-GB进行中（未招募）1 期
A dose finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes - Pre=Point
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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 2 years to 7 years who: A. have a multiplex first degree family history of type 1 diabetes (both parents, parent and sibling, or two siblings); and have one of the following HLA genotypes: DR4DQA1* 0301DQB1* 0302 / DR3DQA1* 0501DQB1* 0201 DR4DQA1* 0301DQB1* 0302 / DR4DQA1* 0301DQB1* 0302 DR4DQA1* 0301DQB1* 0302 / DR4DQA1* 0301DQB1* 0201 DR4DQA1* 0301DQB1* 0302 / DR4DQA1* 0301DQB1* 0304 or B. have a sibling with type 1 diabetes; and are identical by descent for the HLA DR3/DR4DQ8 genotype with their diabetic sibling; 2. Islet autoantibody negative at time of recruitment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives. 2. Prior or current participation in another intervention trial. 3. Chronic oral steroid use and/or other chronic oral immunosuppressant therapy
研究者
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