Yükleniyor... / Loading...
This study examined the effect of the IL-2 drug Aldesleukin (Proleukin) on regulatory T cells in patients with type 1 diabetes. It included patients aged 18-50 diagnosed within the past 24 months who had at least one positive autoantibody. The study was conducted in Phase 1/Phase 2 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: * 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 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 * 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