EUCTR2013-002248-98-IT进行中（未招募）1 期
Anti-CD3 MAB (Teplizumab) for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus - TN-10
TRAILNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA0 个研究点目标入组 71 人开始时间: 2021年1月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
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. Participant in TrialNet Natural History Study (TN01) and thus a relative of a proband** with T1DM.
- •2. Between the ages of 1-45 years at the time of enrollment in TN01 and age = 8 at time of randomization in this trial
- •3. Subject (or parent or legal guardian if the subject is a minor) is willing to provide Informed Consent.
- •4. Individuals <18 years of age at time of randomization must have had a TrialNet conducted OGTT demonstrating abnormal
- •glucose tolerance*
- •within 7 weeks (52 days) of the baseline visit (visit 0).
- •5. Individuals =18 years of age at time of randomization must have had two consecutive TrialNet conducted OGTT's demonstrating
- •glucose tolerance, the most recent of which must have been within 7 weeks (52 days) of the baseline visit (visit 0).
- •6. The participant must be positive for two or more diabetes-related autoantibodies on two occasions. The second occasion must
- •occur within the six months prior to study drug administration, but does not need to involve the same two autoantibodies as were
- •found on the first occasion.
- •The autoantibodies that are to be confirmed are anti-GAD65, anti-ICA512, anti-insulin (MIAA), ZnT8 and/or ICA.
- •7. Weigh at least 26 kg at randomization.
- •8. If participant is female with reproductive potential, she must have a negative pregnancy test on Day 0 and be willing to avoid
- •pregnancy for at least one year from randomization.
- •9. If participant is male, he must be willing to avoid pregnancy in any partners for at least one year from randomization.
- •10. Willing and medically acceptable to postpone live vaccine immunizations for one year after treatment.
- •11. Willing to forego other forms of experimental treatment during the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. If =18yo: Diabetes, or have a screening OGTT with:
- •a. Fasting plasma glucose =126 mg/dL, or
- •b. 2 hour plasma glucose = 200mg/dL
- •2. If <18yo: Diabetes, or have a screening random glucose =200mg/dL
- •3. Lymphopenia (< 1000 lymphocytes/µL).
- •4. Neutropenia (< 1500 PMN/µL ).
- •5. Thrombocytopenia (< 150,000 platelets/µL).
- •6. Anemia (Hgb < 10 grams/deciliter [g/dL]).
- •7. AST or ALT >1.5 x ULN.
- •8. Total bilirubin >1.5 x upper limit of normal (ULN) with the exception of subjects with the
- •diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to
- •hyperbilirubinemia.
- •9. INR > 0.1 above the upper limit of normal at the participating center's laboratory.
- •10. Chronic active infection other than localized skin infections.
- •11. A positive PPD test.
- •12. Vaccination with a live virus within 8 weeks of randomization
- •13. Vaccination with a killed virus within 4 weeks of randomization.
- •14. A history of infectious mononucleosis within the 3 months prior to enrollment.
- •15. Laboratory or clinical evidence of acute infection with EBV or CMV.
- •16. Serological evidence of current or past HIV, Hepatitis B or Hepatitis C infection.
- •17. Be currently pregnant or lactating, or anticipate getting pregnant.
- •18. Chronic use of steroids or other immunosuppressive agents.
- •19. A history of asthma or atopic disease requiring chronic treatment.
- •20. Untreated hypothyroidism or active Graves' disease at randomization.
- •21. Current use of non-insulin pharmaceuticals that affect glycemic control.
- •22. Prior OKT®3 or other anti-CD3 treatment.
- •23. Administration of a monoclonal antibody within the year before randomization.
- •24. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks
- •before randomization.
- •25. Any condition that, in the opinion of the investigator, would interfere
- •with the study conduct or the safety of the subject.
研究者
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