Status:
COMPLETED
Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-14 years
Phase:
PHASE2
Brief Summary
Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system. At high doses, rhIL-2 activates the immune effectors T cells (TEF...
Detailed Description
Main objective: Define the lowest dose of rhIL-2 inducing TREGS in children with recently diagnosed type 1 diabetes. Conduct of the study: Three doses will be studied versus placebo in parallel gro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01862120
Start Date
June 27 2013
End Date
March 16 2017
Last Update
November 12 2020
Active Locations (6)
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1
Service d'Endocrinologie Pédiatrique
Le Kremlin-Bicêtre, France, 94275
2
Service de Pédiatrie - CHU de Nîmes
Nîmes, France, 30029 cedex 9
3
CIC pédiatrique - CHU de Necker
Paris, France, 75015
4
Service d'endocrinologie pédiatrique - CHU de Necker
Paris, France, 75015