Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01862120
Eligibility Criteria:
Inclusion criteria :
* Age \[7-13\] years for girls and \[7-14\] years for boys
* With a T1D diagnosis (as ADA)
* Treated with insulin for ≤ 3 months,
* With at least one auto-antibody among: anti-insulin, anti-GAD, anti-IA2, anti-ZnT8 ;
* No clinically relevant abnormal findings for haematology, biochemistry, liver and kidney functions
* Informed consent signed by the patient, the parents, and the investigator before any intervention necessary for the trial.
Exclusion criteria :
* Contra-indications to IL-2 :
* Hyper sensibility to IL-2 or its excipients,
* Severe cardiopathy
* Previous organ allograft
* Ongoing infection requiring antibiotherapy,
* O2 Saturation ≤ 90 %
* Severe impairment of any vital organ
* Documented history of other auto-immune diseases (except for auto-antibodies for, IAA, GADA, IA-2A, anti-ZnT8A, and stable thyroiditis with normal TSH (\<10 mUI/L), T3 and, T4 levels.
* Diabetes onset characteristics including:
* Continuous nocturnal polyuria ≥ 3 months ;
* Inaugural acidosis (with venous Ph \< 7.25) ;
* HbA1c at diagnostic ≥ 13%;
* Weight loss ≥ 10 % at diagnosis ;
* Positive autoantibodies to 21-hydroxylase
* Stage 2 obesity
* Non authorized concomitant treatment : immuno-modulators, cytotoxic drugs, drug modifying plasma glycemia
* vaccination ≤ 4 weeks with life vaccin
* Positive serology (IgM) to the Epstein-Barr virus (EBV) and/or cytomegalovirus (CMV), reflecting an acute infection.
* Participation to another clinical investigation in previous 3 months
* No affiliation to National Health Insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
14 Years
Study:
NCT01862120
Study Brief:
Protocol Section:
NCT01862120