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

Phase 1

• Registration Number: EUCTR2005-001621-29-GB
• Lead Sponsor: Dresden University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified