EUCTR2013-002249-13-FI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7月15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.
- •2. Between the ages of 1-45 years at the time of enrollment in TN01 and age = 6 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 (defined as having begun menses), willing to avoid pregnancy during treatment with Abatacept and up to 14 weeks after the last dose 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 or within 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. 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).
- •13. Have a history of malignancies.
- •14. Have Mulitiple Sclerosis
- •15. Have demonstrated allergies to abatacept or any of its excipients (maltose, dihydrogen phosphate monohydrate and sodium chloride.)
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已完成
2 期
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