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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01353833
Eligibility Criteria:
Inclusion Criteria:
* Age \[18-50\] years;
* With a T1D:
* Treated with insulin for ≤ 2 years,
* With at least one auto-antibody among: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 ;
* No clinically relevant abnormal value for hematology, biochemistry, liver and kidney function
* Lymphocyte \[1000-4000\]/ mm3
* Informed consent signed by the patient and the investigator before any intervention necessary for the trial.
Exclusion Criteria:
* Contra-indications to IL2 :
* Hypersensibility to IL-2 or its excipients,
* Severe cardiopathy
* Ongoing infection requiring antibiotherapy,
* O2 Saturation ≤ 90 %
* Severe impairment of a vital organ
* Previous organ allograft
* Non authorized concomitant treatment : i.e. immuno-modulators, cytotoxic, drug modifying glycemia
* Cancer progressing or cured for less than 5 years except for primary basal cell carcinoma or carcinoma in situ of the uterine cervix.
* Participation to another clinical investigation in \< 3 months
* Pregnant or lactating women
* Male or female in age of procreation without efficient contraception during the study
* No affiliation to National Health Insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01353833
Study Brief:
Protocol Section:
NCT01353833