NCT00962026已完成1 期
A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence and severity of infection in study participants
研究概览
简要总结
This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 5 years of diagnosis of type 1 diabetes
- •Between the ages of 16 to 45 years
- •Have at least one diabetes-related autoantibody present
- •Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test
- •Be taking insulin
- •Complete written informed consent
排除标准
- •Taking inhaled or oral steroids (for example Advair, Orapred)
- •Have an active infection
- •Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
- •Have ongoing use of medications known to affect glucose tolerance
- •Have a live vaccine 90 days prior to, or during this study
- •Taking any other experimental medication within the past 28 days
- •Have prior treatment with rilonacept
- •Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
- •Pregnant or lactating females
- •Males and females unwilling to use an acceptable method of contraception for the duration of the study
研究组 & 干预措施
Rilonacept
Experimental
干预措施: Rilonacept (Drug)
结局指标
主要结局
Incidence and severity of infection in study participants
时间窗: 7 months
次要结局
- Incidence and severity of other adverse effects in study participants(7 months)
- Changes in participants' sex steroids (testosterone/estradiol)(7 months)
- Changes in participants' HbA1c levels, insulin doses, and beta cell preservation(7 months)
研究者
Perrin C White
Director of Pediatric Endocrinology
University of Texas Southwestern Medical Center
研究点 (1)
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