[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646614":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":49,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":49,"studyType":101,"phases":102,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":111,"whyStopped":49,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"standard treatment group","ACTIVE_COMPARATOR","【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】\n\n1. IVIG 2g\u002Fkg once, given over 8 to 12 hours;\n2. Aspirin 30 mg\u002Fkg in oral per day (given in 3 divided doses), then 3 to 5 mg\u002Fkg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after illness onset.\n\nParticipants with persistent or recurrent fever (temperature of ≥38°C ) 36 hours after completion of the first IVIG infusion are defined as having resistance to IVIG and will receive rescue therapy. The rescue therapy will be chosen on the basis of participant's condition and the physician's experience.\n\nParticipants intolerant to aspirin may receive oral clopidogrel as an alternative.",[13,14],"Drug: IVIG","Drug: Aspirin",{"label":16,"type":17,"description":18,"interventionNames":19},"Firsekibart + standard treatment group","EXPERIMENTAL","1. Firsekibart 3 mg\u002Fkg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.\n2. IVIG 2g\u002Fkg once, given over 8 to 12 hours;\n3. Aspirin 30 mg\u002Fkg in oral per day (given in 3 divided doses), then 3 to 5 mg\u002Fkg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.\n\n【Standard treatment also follow the 2024 AHA Guidelines of Kawasaki Disease】\n\nDiscomfort occurring during the observation period after Firsekibart will be treated symptomatically, and standard treatment will subsequently be provided as needed based on the participant's condition and the physician's experience.\n\nIn the event of a Grade ≥3 allergic reaction, epinephrine will be administered as needed.\n\nManagement of IVIG resistance, aspirin intolerance will be the same as in the control group.",[13,14,20],"Drug: Firsekibart",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","IVIG","IVIG 2g\u002Fkg once, given over 8 to 12 hours, with the maximum dose of 60g.",[16,9],[28],"Intravenous Immunoglobulins, Human",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Aspirin","Aspirin 30 mg\u002Fkg in oral per day (given in 3 divided doses), then 3 to 5 mg\u002Fkg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.",[16,9],[34],"Acetylsalicylic acid",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Firsekibart","Firsekibart 3 mg\u002Fkg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.",[16],[40],"Interleukin (IL)-1β receptor antagonist",[42],{"name":43,"affiliation":5,"role":44},"Fang Liu, MD","STUDY_DIRECTOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","+86 021-64932800",null,"liufang@fudan.edu.cn",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Lan He, MD","+8602164932026","helan0361@163.com",[56,72],{"facility":57,"status":49,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Jiangxi Provincial Children's Hospital","Nanchang","Jiangxi","330006","China","CN",{"type":64,"coordinates":65},"Point",[66,67],115.85306,28.68396,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":49,"phoneExt":49,"email":49},"Xiaohui Liu, MD",{"facility":5,"status":49,"city":73,"state":74,"zip":75,"country":61,"countryCode":62,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Shanghai","Shanghai Municipality","201102",{"type":64,"coordinates":77},[78,79],121.45806,31.22222,{"lat":79,"lon":78},[82],{"name":43,"role":47,"phone":49,"phoneExt":49,"email":49},{"type":84,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[86],{"name":87,"class":6},"Jiangxi Province Children's Hospital","100646614","phase-2-efficacy-and-safety-of-immunoglobulin-plus-firsekibart-in-patients-with-kawasaki-disease-100646614",false,"NCT07686770","Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease","Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study","Inclusion Criteria:\n\n1. Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024\n2. Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)\n3. Not treated with IVIG yet\n4. Age \\>28 days，\\\u003C18 years\n\nExclusion Criteria:\n\n1. Receiving steroids or other immunosuppressive agents in the previous 30 days;\n2. With a previous history of KD;\n3. Afebrile before enrolment;\n4. Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;\n5. Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients;\n6. With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza, etc;\n7. With serious immune diseases, such as immunodeficiency, or chromosomal abnormalities;\n8. With severe hepatic dysfunction (ALT \\> 3 times the upper limit of normal) prior to treatment\n9. Unwillingness to provide written informed consent;\n10. Unlikely to complete at least 3 months of follow-up;\n11. Any other conditions deemed unsuitable for enrolment by investigators.","ALL","29 Days","17 Years",{"count":99,"type":100},90,"ESTIMATED","INTERVENTIONAL",[103,104],"PHASE2","PHASE3","This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin \\[IVIG\\] plus aspirin) in children with Acute Kawasaki Disease (KD) .",[107],"Kawasaki Disease",[107,36,109,110],"Coronary Artery Lesion","IVIG-resistant","NOT_YET_RECRUITING","2026-07-24",{"date":114,"type":115},"2026-07-27","ACTUAL",{"date":117,"type":100},"2026-08-01",{"date":119,"type":100},"2028-02-01",{"name":5,"class":6},2]