Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT01827735
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01827735
Study Brief:
Protocol Section:
NCT01827735