NCT04003844已完成4 期
Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and IVIG-SN 10% 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 CALs
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).
详细描述
This is a multicenter, single-arm, and open-label clinical trial to evaluate the coronary artery lesions (CALs) at 2 and 7 weeks after single dose of IGIV 10% (2 g/kg) administration for at least 12 hours to evaluate the efficacy and safety of IGIV 10%.
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
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children aged 3 months to 7 years inclusive, at the time of signing the informed consent, however, patients with complete KD are eligible up to 12 years (applies to 2A)
- •Subjects with fever 4-10 days meeting one of following criteria (A, B or C)
- •A. Subjects with at least 4 of the following principal clinical findings:
- •i) Bilateral bulbar conjunctival injection without exudate
- •ii) Erythema and cracking of lips, strawberry tongue, and/or erythema of oral and pharyngeal mucosa
- •iii) Erythema and edema of the hands and feet in acute phase and/or periungual desquamation in subacute phase
- •iv) Cervical lymphadenopathy (≥1.5 cm diameter), usually unilateral
- •v) Rash: maculopapular, diffuse erythroderma, or erythema multiforme-like
- •B. Subjects with at least 3 of the principal clinical findings and coronary artery abnormalities detected by 2-dimensional echocardiography: Z score of left anterior descending coronary artery or right coronary artery ≥2.5
- •C. Subjects without coronary artery abnormalities, but with fever ≥5 days, 2 or 3 of the principal clinical findings , CRP of ≥3.0 mg/dL and meeting 3 or more of the following laboratory findings:
- •i) Albumin <3.0 g/dL
- •ii) Anemia for age
- •iii) Elevated alanine aminotransferase level
- •iv) Platelet count of >450,000/mm3 after the 7th day of fever
- •v) White blood cell count of >15,000/mm3
- •vi) Urine >10 white blood cells/high-power field
- •Subjects whose subject's parents or legally authorized representative gave voluntary written consent to participate in the clinical trial
排除标准
- •Subjects with a history of KD
- •Subjects with following laboratory findings:
- •A. Platelet count <100,000/mm3
- •B. WBC count <3,000 cells/mm3
- •C. hemoglobin, hematocrit or red blood cell count more than 30% above the upper limit or 30% below the lower limit of the normal range
- •Subjects who are currently receiving or who have received any investigational drug or device within 30 days prior to administration of the IP
- •Subjects who have received TNF alpha antagonist or systemic corticosteroids within 48 hours prior to administration of the IP
- •Subjects who are considered by the investigator to be an unsuitable candidate for the study due to a severe chronic disease (e.g. cardiovascular disease except controllable hypertension, respiratory disease with respiratory failure, metabolic disease, renal failure, hemoglobinopathy, etc.)
- •Subjects who have received immunosuppressive or immunomodulatory drugs within 3 months prior to administration of the IP
- •Subjects with immunodeficiency including known positive serology for human immunodeficiency virus (HIV)
- •Subjects with a history of hypersensitivity or shock to IVIG formulations
- •Subjects with underlying liver disease or liver dysfunction with known etiology
- •Subjects with renal impairment whose creatinine level is more than twice the upper limit of the normal range
- •Subjects with a history of malignant tumor
- •Subjects with a history of IgA deficiency
- •Subjects who are considered by the investigator to be an unsuitable candidate for the study for any reason
研究组 & 干预措施
Experimental
Experimental
Investigational product (IP)
干预措施: Immunoglobulin G (Drug)
Experimental
Experimental
Investigational product (IP)
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
incidence of CALs
时间窗: 7 weeks
incidence of CALs at 7 weeks after treatment
次要结局
- IGIV resistance(baseline)
- vital signs: blood pressure(7 weeks)
- vital signs: body temperature(7 weeks)
- total duration of fever(baseline)
- laboratory measurements : markers of inflammation and cardiovascular disease(7 weeks)
- incidence of CALs(2 weeks)
- laboratory measurements : hematological parameters(7 weeks)
- physical examination(7 weeks)
- laboratory measurements : clinical chemistry parameters(7 weeks)
- adverse events, adverse drug reactions and serious adverse events(7 weeks)
- laboratory measurements : urinalysis(7 weeks)
研究者
研究点 (7)
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