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2014年6月17日
适应症A soluble fusion protein, CTLA-4 Ig, is to be used for the prevention ofabnormal glucose tolerance and diabetes in relatives at risk ofdeveloping the disease.MedDRA version: 21.1Level: PTClassification code 10066284Term: Diabetes prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- A soluble fusion protein, CTLA-4 Ig, is to be used for the prevention ofabnormal glucose tolerance and diabetes in relatives at risk ofdeveloping the disease.
- 发起方
- TrialNet Coordinating Center
- 入组人数
- 206
- 状态
- 进行中（未招募）
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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.
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.
结局指标
主要结局
未指定
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已完成
2 期
CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1Abnormal Glucose ToleranceType 1 DiabetesNCT01773707National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)212