EUCTR2013-002249-13-DE进行中（未招募）1 期
CTLA-4Ig (Abatacept) for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
TrialNet Coordinating Center0 个研究点目标入组 206 人开始时间: 2014年6月17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
- 206
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
- •Study subjects must be or have:
- •1. Participant in TrialNet Natural History/Pathway to Prevention Study
- •(TN01) and thus, a relative of a proband with T1DM. Please note that participants must be related to a Type 1 diabetic in the 1st or 2nd degree of kinship to take part in the TN18 study in Germany. TN01 participants with a 3rd or 4th degree relative proband will not be eligible to participate in TN18 in Germany.
- •2. Between the ages of 1-45 years at the time of enrollment in TN01 and
- •age = 12 at time of randomization in this trial.
- •3. Willing to provide Informed Consent or have a parent or legal
- •guardian provide informed consent the subject is <18 years of age.
- •4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52
- •days) of baseline (visit 0). If previous abnormal glucose tolerance, has
- •had two consecutive OGTTs with normal glucose tolerance.
- •a. Fasting plasma glucose < 110 mg/dL (6.1 mmol/L), and
- •b. 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), and
- •c. 30, 60, or 90 minute value on OGTT< 200mg/dL (11.1 mmol/L)
- •5. At least two diabetes-related autoantibodies confirmed to be present
- •on two occasions, not including mIAA*. Confirmation of 2 positiveautoantibodies must occur within the six months prior to randomization,
- •but the confirmation does not have to involve the same 2 autoantibodies.
- •6. Weight = 16 kg at Baseline Visit.
- •7. If a female participant with reproductive potential, willing to avoid
- •pregnancy and undergo pregnancy testing prior to each infusion.
- •8. At least three months from date of last live immunization.
- •9. Willing to forgo live vaccines while receiving treatment on study and
- •for three months following last study drug administration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 103
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 103
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Potential participants must not meet any of the following exclusion
- •1. Abnormal Glucose Tolerance or Diabetes
- •a. Fasting plasma glucose = 110 mg/dL (6.1 mmol/L), or
- •b. 2 hour plasma glucose = 140 mg/dL (7.8 mmol/L), or
- •c. 30, 60, 90 minute plasma glucose during OGTT = 200 mg/dL (11.1
- •2. Insulin autoantibodies (mIAA).
- •3. Immunodeficient or have clinically significant chronic lymphopenia.
- •4. 4. Have an active infection at time of randomization.
- •5. Have a positive PPD test result or history of previously treated TB, or positive interferon-gamma release assay (IGRA) test.
- •6. Be currently pregnant or lactating, or anticipate getting pregnant within 14 weeks of the last study drug administration.
- •7. Use of medications known to influence glucose tolerance.
- •8. Require use of other immunosuppressive agents.
- •9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
- •10. Have serological evidence of current CMV infection.
- •11. Have evidence of active EBV infection.
- •12. Have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).
- •13. Have a history of malignancies.
- •14. Have Multiple Sclerosis.
- •15. Have demonstrated allergies to abatacept or any of its excipients (maltose, sodium dihydrogen phosphate monohydrate and sodium chloride).
- •4. Have an active infection at time of randomization.
- •5. Have a positive PPD test result or history of previously treated TB, or
- •positive interferongamma release assay (IGRA) test.
- •6. Be currently pregnant or lactating, or anticipate getting pregnant
- •within 3 months of the last study drug administration.
- •7. Use of medications known to influence glucose tolerance.
- •8. Require use of other immunosuppressive agents.
- •9. Have serologic evidence of current or past HIV, Hepatitis B (positive
- •for Hepatitis B core
- •antibody or surface antigen), or Hepatitis C infection.
- •10. Have serological evidence of current CMV infection.
- •11. Have evidence of active EBV infection.
- •12. Have any complicating medical issues or abnormal clinical laboratory
- •results that interfere with study conduct or cause increased risk. These
- •include pre-existing cardiac disease, COPD, neurological, or blood count
- •abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).
- •Have a history of malignancies.
- •4. Have an active infection at time of randomization.
- •5. Have a positive PPD test result or history of previously treated TB, or
- •positive interferongamma release assay (IGRA) test.
- •6. Be currently pregnant or lactating, or anticipate getting pregnant
- •within 3 months of the last study drug administration.
- •7. Use of medications known to influence glucose tolerance.
- •8. Require use of other immunosuppressive agents.
- •9. Have serologic evidence of current or past HIV, Hepatitis B (positive
- •for Hepatitis B core
- •antibody or surface antigen), or Hepatitis C infection.
- •10. Have serological evidence of current CMV infection.
- •11. Have evidence of active EBV infection.
- •12. Have any complicating medical issues or abnormal clinical laboratory
- •results that interfere with study conduct or cause increased risk. These
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研究者
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