Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-03-15 @ 4:43 AM
Study NCT ID:
NCT02951234
Status:
UNKNOWN
Last Update Posted:
2018-03-06
First Post:
2016-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-12', 'releaseDate': '2023-04-06'}, {'resetDate': '2024-08-01', 'releaseDate': '2024-02-21'}], 'estimatedResultsFirstSubmitDate': '2023-04-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009080', 'term': 'Mucocutaneous Lymph Node Syndrome'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coronary artery lesions', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'IVIG resistance', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery lesions', 'intravenous immunoglobulin', 'Kawasaki disease', 'randomized clinical trial', 'aspirin'], 'conditions': ['Kawasaki Disease']}, 'referencesModule': {'references': [{'pmid': '40178858', 'type': 'DERIVED', 'citation': 'Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Han Z, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Guo MM, Yang KD, Sylvester KG, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253063. doi: 10.1001/jamanetworkopen.2025.3063.'}, {'pmid': '39040184', 'type': 'DERIVED', 'citation': 'Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Chang LS, Guo MM, Yang KD, Sylvester KG, Han Z, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN ALONE ON CORONARY ARTERY LESION REDUCTION IN KAWASAKI DISEASE. medRxiv [Preprint]. 2024 Jul 12:2024.07.11.24310310. doi: 10.1101/2024.07.11.24310310.'}, {'pmid': '29933749', 'type': 'DERIVED', 'citation': 'Kuo HC, Guo MM, Lo MH, Hsieh KS, Huang YH. Effectiveness of intravenous immunoglobulin alone and intravenous immunoglobulin combined with high-dose aspirin in the acute stage of Kawasaki disease: study protocol for a randomized controlled trial. BMC Pediatr. 2018 Jun 22;18(1):200. doi: 10.1186/s12887-018-1180-1.'}]}, 'descriptionModule': {'briefSummary': 'Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.', 'detailedDescription': 'Background: Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. High-dose aspirin is often administered, but the duration of such treatment varies. Many centers reduce the aspirin dose once the patient is afebrile, even before treating said patient with IVIG. However, a randomized controlled trial regarding high-dose aspirin in the acute stage of KD has not previously been carried out.\n\nMethods/design: This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks. Patients meeting the eligibility criteria are randomly assigned (1:1) to a test group (that receives only IVIG) or a standard group (that receives IVIG plus high-dose aspirin). This clinical trial is conducted at seven medical centers in Taiwan.\n\nDiscussion: Since high-dose aspirin has significant anti-inflammatory and anti-platelet functions, it does not appear to lower the frequency of disease outcomes. Furthermore, it can decrease hemoglobin levels. Therefore, the investigators have initiated this randomized controlled trial to determine whether high-dose aspirin is necessary in the acute stage of KD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Male or female, under the age of 7 years old.\n\n2\\. Fulfilled the AHA criteria for KD as explained below:\n\n1. Fever (more than 38.0℃ ear temperature) \\> or = 5 days, as well as 4 of the 5 following symptoms\n2. Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)\n3. Bilateral non-purulent conjunctivitis\n4. Dysmorphous skin rashes\n5. Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes\n6. Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter)\n\n3\\. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian.\n\n\\-\n\nExclusion Criteria:\n\n1. Had symptoms that did not completely match the KD criteria.\n2. Had an acute fever for \\< 5 days and \\>10 days\n3. IVIG treatment at another hospital before being referred to the study center.\n4. Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;\n5. The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).\n6. Previous KD diagnosis.\n7. Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.)\n8. Afebrile prior to enrollment\n9. CAL prior to enrollment\n10. Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.)\n11. Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza\n12. Judged by the researcher to be unsuitable for this trial.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02951234', 'briefTitle': 'A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan', 'orgStudyIdInfo': {'id': 'IVIG And Aspirin in KD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVIG only', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.', 'interventionNames': ['Other: IVIG only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVIG and Aspirin', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.', 'interventionNames': ['Other: IVIG and Aspirin']}], 'interventions': [{'name': 'IVIG only', 'type': 'OTHER', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.', 'armGroupLabels': ['IVIG only']}, {'name': 'IVIG and Aspirin', 'type': 'OTHER', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.', 'armGroupLabels': ['IVIG and Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81362', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ken-Pen Weng, MD', 'role': 'CONTACT', 'email': 'kenpenweng@yahoo.com.tw', 'phone': '+886-975581955'}], 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ho-Chang Kuo, MD, PhD', 'role': 'CONTACT', 'email': 'erickuo48@yahoo.com.tw'}, {'name': 'Ying-Hsien Huang, MD, PhD', 'role': 'CONTACT', 'email': 'yhhuang123@yahoo.com.tw'}], 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40705', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Chih Lin, MD', 'role': 'CONTACT', 'email': 'mingclin@gmail.com', 'phone': '+886-917620556'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '433', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chung-Chih Kao, MD', 'role': 'CONTACT', 'email': 'cckao2cv@yahoo.com', 'phone': '+886-935279276'}], 'facility': "Tungs' Taichung Metroharbor Hospital", 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Jung Chen, MD', 'role': 'CONTACT', 'email': 'chinjung@adm.cgmh.org.tw'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ho-Chang Kuo, MD, PhD', 'role': 'CONTACT', 'email': 'erickuo48@yahoo.com.tw'}, {'name': 'Ying-Hsien Huang, MD, PhD', 'role': 'CONTACT', 'email': 'yhhuang123@yahoo.com.tw'}], 'overallOfficials': [{'name': 'Ho-Chang Kuo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-04-06', 'type': 'RELEASE'}, {'date': '2024-01-12', 'type': 'RESET'}, {'date': '2024-02-21', 'type': 'RELEASE'}, {'date': '2024-08-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chang Gung Memorial Hospital'}}}}