Status:
COMPLETED
Regulatory T Cells in Type 1 Diabetes Patients Treated With IL-2
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Cambridge
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing pancreatic beta ce...
Eligibility Criteria
Inclusion
- Written informed consent
- Type 1 diabetes
- 18-50 years
- Duration of diabetes less than 24 months from diagnosis
- One positive autoantibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)
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
- 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 impaired liver function
- Positive Hepatitis B surface Antigen (HBsAg) or Hepatitis C serology or Human Immunodeficiency Virus (HIV) test
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01827735
Start Date
March 1 2013
End Date
May 1 2014
Last Update
June 23 2015
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ