EUCTR2019-003265-17-BE进行中（未招募）1 期
Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D) - MELD-ATG
niversitair Ziekenhuis Leuven (UZ Leuven)0 个研究点目标入组 114 人开始时间: 2020年7月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
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
- 性别
- All
入选标准
- •1. Has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individuals under the age of consent will be asked to assent to trial participation.
- •2. Be aged =5 years to =25 years at written informed consent/assent
- •3. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
- •4. Have random C-peptide levels =200 pmol/L measured at screening, as tested centrally
- •5. Have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
- •6. Will be =6 weeks from last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
- •7. Be willing to comply with intensive diabetes management
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 107
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Type 2 diabetes
- •2. Evidence of prior or current tuberculosis (TB) infection
- •3. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including:
- •- Immunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia or thrombocytopenia at the screening visit, according to local reference ranges
- •- Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN), at screening
- •- Evidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening, adjusted for the age of the patient
- •- Clinically significant clotting disorder, according to local reference ranges
- •4. Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
- •5. Any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
- •6. Seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection at screening
- •7. Positive for SARS-CoV-2 based on local testing regimen
- •8. Unwilling to use appropriate contraception if sexually active during the trial, from date of written informed consent until completion of the 12-month follow up visit
- •9. Any history of malignancies
- •10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control
- •11. Active participation in another T1D treatment interventional trial in the previous 30 days prior to screening (excluding treatment with insulin)
- •12. Any prior treatment with ATG, Abatacept or anti-CD3
- •13. Known allergy to ATG or to similar products, or hypersensitivity to rabbit proteins or to any of the excipients
- •14. Any condition, complicating medical issues, or abnormal clinical laboratory results that the investigator judges may adversely affect trial conduct, cause increased risk to the participant, or compromise the trial results
- •15. Pregnant and breastfeeding women
研究者
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