Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-14 @ 9:00 PM
Study NCT ID:
NCT01666795
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibody Specificity and Response to IVIG in ITP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'initial response', 'timeFrame': 'within 7 days of dosing', 'description': 'The criteria for an initial response was a platelet count ≥ 30 × 109/L and doubling of the baseline count within 7 days of dosing (confirmed on at least 2 separate occasions at least 7 days apart), and absence of bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Immune Thrombocytopenia (ITP)']}, 'referencesModule': {'references': [{'pmid': '24517219', 'type': 'DERIVED', 'citation': 'Peng J, Ma SH, Liu J, Hou Y, Liu XM, Niu T, Xu RR, Guo CS, Wang XM, Cheng YF, Ni H, Hou M. Association of autoantibody specificity and response to intravenous immunoglobulin G therapy in immune thrombocytopenia: a multicenter cohort study. J Thromb Haemost. 2014 Apr;12(4):497-504. doi: 10.1111/jth.12524.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.', 'detailedDescription': 'Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies assayed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) the diagnosis of ITP was based on the presence of isolated thrombocytopenia and the absence of any obvious initiating and/or underlying cause of the thrombocytopenia in accordance with the recently released international consensus guidelines,(2) a diagnosis was established during the 4 weeks prior to initiation of IVIG treatment, (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/L, and (5) a bleeding score ≥ 9 at the time of admission according to the clinical scoring system described by Khellaf et al. to assess the severity of hemorrhage.\n\nExclusion Criteria:\n\n* a history of any ITP-specific treatment administered prior to or concomitantly with the IVIG'}, 'identificationModule': {'nctId': 'NCT01666795', 'briefTitle': 'Autoantibody Specificity and Response to IVIG in ITP', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Autoantibody Specificity and Response to Intravenous Immunoglobulin G (IVIG) in Immune Thrombocytopenia (ITP): a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ITP-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVIG therapy in ITP', 'description': 'IVIG therapy in untreated adults with severe ITP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Ming Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Medical College Shandong University', 'class': 'OTHER'}, {'name': 'Jinan Military General Hospital', 'class': 'OTHER'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Hematology, Qilu Hospital, Shandong University', 'investigatorFullName': 'Ming Hou', 'investigatorAffiliation': 'Shandong University'}}}}