Status:
ACTIVE_NOT_RECRUITING
Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Oxford Clinical Trials Research Unit (OCTRU)
Centre for Statistics in Medicine, Oxford
Conditions:
Type1 Diabetes
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes. One group will receive ald...
Detailed Description
Investigators know that the longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and long-term complications. People get type 1 di...
Eligibility Criteria
Inclusion
- Have given written informed consent to participate or assent with parental consent
- Be aged 6-18 years
- Be diagnosed with T1D (Type 1 Diabetes) (at least one autoantibody positive), requiring insulin treatment
- Be within 6 weeks from diagnosis of T1D (at screening)
- Have a random C-peptide \> 200 pmol/l
- Normal full blood count
Exclusion
- Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
- Pre-existing autoimmune disease (excluding type 1 diabetes)
- Hypersensitivity to aldesleukin or any of the excipients
- History of severe cardiac disease (NYHA Class III or IV)
- History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- Clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function
- Pre-existing severe major organ dysfunction or seizure disorders
- Participation in another clinical trial (CTIMP) within 4 months prior to screening
- Females who are pregnant, lactating or intend to get pregnant during the study
- Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
- Sexually active males who are unwilling or unable to comply with contraceptive advice
- Current use of immunosuppressive agents or steroids
- Current treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products
- Active clinical infections - participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern
- Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03782636
Start Date
January 28 2019
End Date
September 1 2026
Last Update
October 3 2025
Active Locations (5)
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1
Oxford Children's Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
2
Bristol Royal Hospital for Children
Bristol, United Kingdom
3
Addenbrooke's Hospital
Cambridge, United Kingdom
4
The Great North Children's Hospital
Newcastle upon Tyne, United Kingdom