EUCTR2017-002126-20-GB进行中（未招募）1 期
Interleukin-2 therapy of Autoimmunity in Diabetes: ITAD - Interleukin-2 Therapy of Autoimmunity in Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Have given written informed consent to participate or assent with parental consent
- •2.Be aged 6-18 years
- •3.Be diagnosed with T1D (at least one autoantibody positive), requiring insulin treatment
- •4.Be within 6 weeks from diagnosis of T1D
- •5.Have a random C-peptide > 200 pmol/l
- •6.Normal full blood count
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
- •2.Uncontrolled thyroid and coeliac diseases
- •3.Hypersensitivity to aldesleukin or any of the excipients
- •4.History of severe cardiac disease (NYHA Class III or IV)
- •a. See Appendix D
- •5.History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- •6. Participation in another clinical trial (CTIMP) within 4 months prior to screening
- •7.Females who are pregnant, lactating or intend to get pregnant during the study
- •8.Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
- •9.Current use of immunosuppressive agents or steroids
- •10.Active clinical infections – participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment
- •11.Immunisations – participants can be recruited after a minimum of 14 days following immunisation. Routine vaccinations should be avoided for the 6-month duration of treatment and for 30 days afterwards
- •12.Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern
- •13.Children with compliance problems
研究者
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