跳至主要内容
临床试验/NCT04747847
NCT04747847已完成早期 1 期

Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年6月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
5
试验地点
1
主要终点
Number of Participants With Treatment-related 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 could lead to complications later in life, including heart attack. Although we 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. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.

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 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

排除标准

  • Taking a CYP3A4 metabolized drug (such as cyclosporine)

研究组 & 干预措施

Atorvastatin and anakinra

Experimental

Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

干预措施: Atorvastatin and anakinra (Drug)

结局指标

主要结局

Number of Participants With Treatment-related Adverse Events

时间窗: 6 weeks

The number of participants with adverse events related to study drugs will be assessed and reported

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana H. Tremoulet

Professor

University of California, San Diego

研究点 (1)

Loading locations...

相似试验