Aldesleukin Therapy in Type 1 Diabetes

Phase 1

• Conditions: Type 1 Diabetes; MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-002126-20-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1.Have given written informed consent to participate or assent with parental consent
2.Be aged 6-18 years
3.Be diagnosed with T1D (at least one autoantibody positive), requiring insulin treatment
4.Be within 6 weeks from diagnosis of T1D
5.Have a random C-peptide > 200 pmol/l
6.Normal full blood count

Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
2.Uncontrolled thyroid and coeliac diseases
3.Hypersensitivity to aldesleukin or any of the excipients
4.History of severe cardiac disease (NYHA Class III or IV)
a. See Appendix D
5.History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
6. Participation in another clinical trial (CTIMP) within 4 months prior to screening
7.Females who are pregnant, lactating or intend to get pregnant during the study
8.Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
9.Current use of immunosuppressive agents or steroids
10.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
11.Immunisations – participants can be recruited after a minimum of 14 days following immunisation. Routine vaccinations should be avoided for the 6-month duration of treatment and for 30 days afterwards
12.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
13.Children with compliance problems

Study & Design

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