EUCTR2018-000659-42-SE进行中（未招募）1 期
HYDROXYCHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSETOLERANCE AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1DIABETES MELLITUS
TrialNet Coordinating Center0 个研究点目标入组 201 人开始时间: 2019年1月21日最近更新:
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
- 201
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. Family history of Type 1 Diabetes or known positivity for one or more diabetes-related autoantibodies.
- •2. Age = 3 years at the time of randomization in this trial.
- •3. Willing to provide informed consent or, if the participant is <18 years of age, have a parent or legal guardian provide informed consent.
- •4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) prior to 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. Two or more diabetes-related autoantibodies present on two separate samples, one of which was drawn within the past six months (210 days). Confirmation does not have to involve the same 2 autoantibodies.
- •6. Weight = 12 kg at the time of screening.
- •7. If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit.
- •8. Anticipated ability to swallow study medication
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 190
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 mmol/L)
- •2. History of treatment with insulin or other diabetes therapies.
- •3. Ongoing use of medications known to influence glucose tolerance, e.g. glucocorticoids, growth hormone, anticonvulsants, thiazide or potassium-depleting diuretics, beta adrenergic blockers, niacin and antipsychotics. Participants on such medications should be changed to a suitable alternative, if available, by their primary care provider, and will become eligible one month after medication is discontinued.
- •4. Ongoing or anticipated future use of any medications known to impact T1D progression or have untoward interactions with hydroxychloroquine.
- •5. Known hypersensitivity to 4-aminoquinoline compounds.
- •6. G6PD deficiency.
- •7. History of retinopathy.
- •8. Active infection at time of randomization.
- •9. Serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
- •10. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
- •11. Be Breastfeeding or pregnant
研究者
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