Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT05520892
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 580}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2022-08-28', 'studyFirstSubmitQcDate': '2022-08-28', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early response to treatment', 'timeFrame': '7 days after treatment', 'description': 'Platelet counts after 7 days of IVIG treatment'}], 'secondaryOutcomes': [{'measure': 'Economic Indicators', 'timeFrame': '1 week', 'description': 'Calculate the total amount of IVIG used in 1 week (weight normalized)'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '1 week', 'description': 'Incidence of Treatment-Emergent Adverse Events in 1 week'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '29 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:\n\n1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment\n2. Age \\> 28 days and ≤ 14 years old\n3. PLT\\<20×109/L\n4. Have signed the informed consent\n\nExclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:\n\n1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy\n2. Received glucocorticoid or IVIG therapy within 6 months\n3. Weight \\> 40kg\n4. Menstrual female patients\n5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases\n6. Patients who have received radiotherapy and chemotherapy\n7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results -"}, 'identificationModule': {'nctId': 'NCT05520892', 'briefTitle': 'Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children', 'orgStudyIdInfo': {'id': '2022YF024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low-dose intravenous immunoglobulin', 'description': '0.4g/kg.d, d1-5', 'interventionNames': ['Drug: intravenous immunoglobulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-dose intravenous immunoglobulin', 'description': '1.0g/kg.d, d1-2', 'interventionNames': ['Drug: intravenous immunoglobulin']}], 'interventions': [{'name': 'intravenous immunoglobulin', 'type': 'DRUG', 'description': 'To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia', 'armGroupLabels': ['high-dose intravenous immunoglobulin', 'low-dose intravenous immunoglobulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaohua Le, Master', 'role': 'CONTACT', 'email': 'lele883@sina.com', 'phone': '8613365917129'}], 'facility': 'Children with newly dignosed ITP', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': "Shaohua Le, Master's degree", 'role': 'CONTACT', 'email': 'lele883@sina.com', 'phone': '8613365917129'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Zhangzhou Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Quanzhou First Hospital', 'class': 'OTHER'}, {'name': 'Nanping First Hospital Affiliated to Fujian Medical University', 'class': 'UNKNOWN'}, {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}, {'name': 'Longyan City First Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Putian University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}