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This study evaluates how the dosing frequency of low-dose IL-2 (Aldesleukin) affects immune-regulating regulatory T cells in patients with type 1 diabetes. It included patients aged 18-70 diagnosed less than 60 months earlier. It was a Phase 1/Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Type 1 diabetes * 18-70 years of age * Duration of diabetes less than 60 months from diagnosis * Written informed consent to participate Exclusion Criteria: * 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%))