Status:
COMPLETED
Adaptive Study of IL-2 Dose Frequency on Regulatory T Cells in Type 1 Diabetes
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Cambridge
Sir Jules Thorn Charitable Trust
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused by the body's immune destruction of its own insulin producing pancreatic beta cells leading to insulin defici...
Eligibility Criteria
Inclusion
- Type 1 diabetes
- 18-70 years of age
- Duration of diabetes less than 60 months from diagnosis
- Written informed consent to participate
Exclusion
- Hypersensitivity to aldesleukin or any of the excipients
- History of severe cardiac disease
- History of malignancy within the past 5 years (with the exception of localized carcinoma of the skin that had been resected for cure or cervical carcinoma in situ)
- History or concurrent use of immunosuppressive agents or steroids
- History of unstable diabetes with recurrent hypoglycaemia
- History of live vaccination two weeks prior to first treatment
- Active autoimmune hyper or hypothyroidism
- Active clinical infection
- Major pre-existing organ dysfunction or previous organ allograft
- Females who are pregnant, lactating or intend to get pregnant during the study
- Males who intend to father a pregnancy during the study
- Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
- Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
- Abnormal ECG
- Abnormal full blood count, chronic renal failure (Stage 3,4,5) and/or evidence of severely impaired liver function (ALT/AST \> 3xULN at screening; alkaline phosphatase and bilirubin 2xULN at screening (isolated bilirubin \>2xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%))
Key Trial Info
Start Date :
October 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02265809
Start Date
October 3 2014
End Date
May 26 2016
Last Update
August 21 2018
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility, Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ