EUCTR2005-001621-29-AT进行中（未招募）不适用
Pre-POINT (Primary Oral/intranasal INsulin Trial) study 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
Faculty of Medicine Carl Gustav Carus, University of Technology, Dresden0 个研究点目标入组 40 人开始时间: 2009年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- All
入选标准
- •1. Children aged 2 years to 7 years who:
- •A. have a multiplex first degree family history of T1DM
- •(both parents, parent and sib, or two sibs);
- •and have one of the following HLA genotypes:
- •DR4- DQA1*0301-DQB1*0302 / DR3- DQA1*0501-DQB1*0201
- •DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0302
- •DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0201
- •DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0304
- •B. have a sibling with T1DM;
- •and are identical by descent for the HLA DR3/DR4-DQ8 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:
- •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. 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
研究者
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The aim of this study is to look at the safety of taking insulin by mouth. Pre-POINT wants to find a dose that causes an immune response. This response will hopefully delay or prevent the start of type 1 diabetes. Children who join this study will get insulin or a placebo (dummy drug) by mouth every day for 3 -18 months. Participants will be closely followed for the development of diabetes autoantibodies and type 1 diabetes for the whole study.pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)EUCTR2005-001621-29-DEFaculty of Medicine Carl Gustav Carus, University of Technology, Dresden25
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