Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.
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
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant or child aged 1 month to 17 years, who meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending (LAD)/right coronary artery (RCA) Z score ≥ 3.0 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary artery segments
- •Patient presents within the first 20 days after fever onset
- •Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as appropriate
- •Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
- •Males engaging in sexual activity that could lead to pregnancy willing to use a condom.
排除标准
- •Use of an IL-1 antagonist within the 3 months prior to enrollment
- •History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
- •History of hypersensitivity to anakinra
- •History of tuberculosis (TB) or TB exposure
研究组 & 干预措施
Anakinra
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
干预措施: Anakinra (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: within 6 weeks of treatment
The primary outcome measure was the safety and tolerability of anakinra
次要结局
未报告次要终点
研究者
Adriana H. Tremoulet
Associate Professor
University of California, San Diego