Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02751593
Status:
UNKNOWN
Last Update Posted:
2016-04-26
First Post:
2016-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombocytopenia in Gestational Period
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2016-04-17', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate (CR+R)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Platelet count', 'timeFrame': '2 years'}, {'measure': 'Adverse events', 'timeFrame': '2 years'}, {'measure': 'live birth rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pregnancy', 'Immune Thrombocytopenia', 'dexamethasone'], 'conditions': ['Immune Thrombocytopenia', 'Pregnancy']}, 'descriptionModule': {'briefSummary': "The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.", 'detailedDescription': "The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is between 20-50 years old.\n* After 12 weeks gestation.\n* Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.\n* Patients who have no response or relapsed after Corticosteroid or IVIG.\n* Patients developed refractoriness to platelet transfusion.\n* To show a platelet count \\< 30×10\\^9/L, and with bleeding manifestations.\n* Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.\n* Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.\n* Current HIV infection or hepatitis B virus or hepatitis C virus infections.\n* Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.\n* Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).\n* Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.\n* Patients who are deemed unsuitable for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT02751593', 'briefTitle': 'Thrombocytopenia in Gestational Period', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Thrombocytopenia in Gestational Period', 'orgStudyIdInfo': {'id': 'pregnancy and thrombocytopenia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexamethasone', 'description': 'dexamethasone 40mg/d for 4 days', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'dexamethasone 40mg/d for 4 days', 'armGroupLabels': ['dexamethasone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xiao-hui Zhang, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}