ISRCTN27852285已完成未知
ADaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D)
Cambridge University Hospitals NHS Foundation trust & University of Cambridge (UK)0 个研究点目标入组 40 人开始时间: 2013年3月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/08/2013:
- •1. Type 1 diabetes
- •2. 18-50 years of age
- •3. Duration of diabetes less than 24 months from diagnosis
- •4. One positive auto-antibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)
- •Previous inclusion criteria:
- •1. Type 1 diabetes
- •2. 18-50 years of age
- •3. Duration of diabetes more than 3 months but less than 24 months from diagnosis
- •4. One positive auto-antibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)
排除标准
- •Current exclusion criteria as of 23/08/2013:
- •1. Hypersensitivity to aldesleukin or any of the excipients
- •2. History of severe cardiac disease
- •3. 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
- •4. History or concurrent use of immunosuppressive agents or steroids.
- •5. History of unstable diabetes with recurrent hypoglycaemia
- •6. Active autoimmune, hyper or hypothyroidism
- •7. Active clinical infection
- •8. Major pre-existing organ dysfunction
- •9. Previous organ allograft
- •10. Females who are pregnant, lactating or intend to get pregnant during the study
- •11. Male who intend to father a pregnancy during the study
- •12. Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
- •13. Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
- •14. Abnormal ECG
- •15. Abnormal full blood count, chronic renal failure, and/or impaired liver function
- •16. Positive HBsAg or HepC serology or HIV test
- •17. 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
- •Previous exclusion criteria:
- •1. Hypersensitivity to aldesleukin or any of the excipients
- •2. History of severe cardiac disease
- •3. 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
- •4. History or concurrent use of immunosuppressive agents or steroids.
- •5. History of unstable diabetes with recurrent hypoglycaemia
- •6. Hyper or hypothyroidism
- •7. Active clinical infection
- •8. Major pre-existing organ dysfunction
- •9. Previous organ allograft
- •10. Females who are pregnant, lactating or intend to get pregnant during the study
- •11. Male who intend to father a pregnancy during the study
- •12. Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
- •13. Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
- •14. Abnormal ECG
- •15. Abnormal full blood count, chronic renal failure, and/or impaired liver function
- •16. Positive HBsAg or HepC serology or HIV test
- •17. 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
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