Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-16 @ 7:58 PM
Study NCT ID:
NCT02540720
Status:
UNKNOWN
Last Update Posted:
2020-02-26
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Research of Standard Diagnosis and Treatment for Severe HSP in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011695', 'term': 'IgA Vasculitis'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007105', 'term': 'Immune Complex Diseases'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'D006464', 'term': 'Hemoperfusion'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'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': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Symptoms of Digestive Tract', 'timeFrame': '2 weeks', 'description': 'The stomachache and other symptoms of digestive tract disappear'}, {'measure': 'The Symptoms of Joint System', 'timeFrame': '2 weeks', 'description': 'The arthralgia disappears'}], 'secondaryOutcomes': [{'measure': 'The Skin Rash', 'timeFrame': '2 weeks', 'description': 'The Skin Rash disappears'}, {'measure': 'Renal function', 'timeFrame': '2 weeks', 'description': 'There is no damage in kidney.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Henoch-Schoenlein Purpura']}, 'referencesModule': {'references': [{'pmid': '36853224', 'type': 'DERIVED', 'citation': 'Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.'}]}, 'descriptionModule': {'briefSummary': 'This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.', 'detailedDescription': "Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.\n\nIn the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.\n\nThe investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days\n\nExclusion Criteria:\n\n* The children with congenital diseases'}, 'identificationModule': {'nctId': 'NCT02540720', 'briefTitle': 'The Research of Standard Diagnosis and Treatment for Severe HSP in Children', 'organization': {'class': 'OTHER', 'fullName': "Nanjing Children's Hospital"}, 'officialTitle': 'The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children', 'orgStudyIdInfo': {'id': 'Zhai'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'Dexamethasone 0.5mg/kg.d i.v.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'Dexamethasone \\& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \\& gamma globulin i.v. qd\\*3d, and the total dose is 2g/kg', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Gamma globulin']}, {'type': 'EXPERIMENTAL', 'label': 'group 3', 'description': 'Dexamethasone \\& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \\& hemoperfusion should be given at least three times in five days', 'interventionNames': ['Drug: Dexamethasone', 'Procedure: Hemoperfusion']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['group 1', 'group 2', 'group 3']}, {'name': 'Gamma globulin', 'type': 'DRUG', 'armGroupLabels': ['group 2']}, {'name': 'Hemoperfusion', 'type': 'PROCEDURE', 'armGroupLabels': ['group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aihua Zhang, M.D.', 'role': 'CONTACT', 'email': 'bszah@163.com', 'phone': '+8618951769017'}], 'facility': "Nanjing Children's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Aihua Zhang, M.D.', 'role': 'CONTACT', 'email': 'bszah@163.com', 'phone': '+8618951769017'}, {'name': 'Yimei Wu', 'role': 'CONTACT', 'email': 'wym891203@163.com', 'phone': '+8615951757930'}], 'overallOfficials': [{'name': 'Aihua Zhang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Department of Nephrology, Nanjing children's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nanjing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital vice president', 'investigatorFullName': 'Aihua Zhang', 'investigatorAffiliation': "Nanjing Children's Hospital"}}}}