NCT01524939已完成4 期
Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Incidence of coronary artery lesions
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
详细描述
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.
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
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 6 months - 5 years
- •Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria
- •Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram.
- •Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial
排除标准
- •Those whose blood test results show abnormalities of significance as follows : Platelet count < 100,000/mm3, WBC count <3,000 cells/mm3,Those whose hemogloblin, hematocrit or red blood cell count exceed 30% of the upper limit of the normal range or are 30% below the lower limit of the normal range.
- •Those who have been administered other clinical product in the last 30 days after this clinical trial commenced
- •Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product
- •Those who plan to be inoculated with live vaccine during the clincial trial period
- •Those considered difficult to participate in clinical trial due to serious chronic diseases(e.g., cardiovascular diseases except controllable hypertension, diseases of the respiratory system concurrent with respiratory failure, metabolic disease, kidney dysfunction, hemoglobinopathy, etc.)
- •Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product
- •Those who are HIV-positive or have immune dysfunctions including immunodeficiency
- •Those who have previously exhibited hypersensitivity or shock to IVIG agents
- •Patients with underlying liver disease or liver dysfunction with known etiology.
- •Patients with kidney dysfunction, whose Creatinine level is found to be over 2 times higher than the upper limit of the normal ranges in a screening test
- •Those who have -- or previously had -- a malignant tumor
- •Those who have previously been diagnosed with IgA deficiency
- •Those found unsuitable for undergoing the tests
研究组 & 干预措施
Investigational product
Experimental
干预措施: immunoglobulin G (Drug)
结局指标
主要结局
Incidence of coronary artery lesions
时间窗: 7 weeks
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion
次要结局
- Incidence of coronary artery lesions(2weeks)
- Total fever duration(baseline)
- variation of ESR, CRP, NT-proBNP,CK-MB(baseline)
研究者
研究点 (7)
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