An immune efficacy study for primary prevention using intranasal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes - PINIT Study

Technische Universität München, Fakultät für Medizin0 个研究点目标入组 38 人开始时间: 2016年9月2日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•1. Written informed consent signed by either both parents or legal guardian(s).
•2. Children aged 1 year to 7 years (randomization must be performed prior to 8th birthday) who:
•a. have the HLA DR3-DQB1*0201/DR4-DQB1*0302 or HLA DR3-DQB1*0201/DR4-DQB1*0304 genotype
•b. 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: DR11, DR12, DQB1*0602, or haplotypes: DR7-DQB1*0303, DR14-DQB1*0503, DR13-DQB1*0603
•3. are islet autoantibody negative (autoantibodies against insulin, GAD, IA-2 and ZnT8) at the time of screening (time between screening sample collection and randomization must not exceed 90 days).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 38
•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

•Participants meeting any of the following criteria will NOT be eligible for inclusion into the study:
•1. Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.
•2. Any condition that could be associated with poor compliance.
•3. Any defect or pathology of nasal passage that would preclude application of the intranasal spray.
•4. Any moderate to severe intolerance to ingredients of the investigational medicinal product.

发起方

Technische Universität München, Fakultät für Medizin