NCT02980263撤回2 期
Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- resolution of fever
研究概览
简要总结
The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
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
- 28 Days 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Kawasaki disease defined as:
- •fever ≥38.5°C for ≥5 days
- •four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy
排除标准
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1)
- •Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2)
- •History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)
- •Other protocol-defined inclusion/exclusion may apply.
研究组 & 干预措施
Kawasaki patients
Experimental
干预措施: Canakinumab (Drug)
结局指标
主要结局
resolution of fever
时间窗: Day 3/4
次要结局
- size of coronary artery aneurysm(24 weeks)
- proportion of patients with coronary artery aneurysm(12 weeks)
- time to resolution of fever(12 weeks)
- proportion of patients with C-reactive Protein reduction(12 weeks)
- proportion of patients with remittent fever(12 weeks)
- Coronary artery aneurysm evolution over time(12 weeks)
- proportion of patients developing coronary artery aneurysms(12 weeks)
研究者
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