Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT01672151
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2012-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia
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': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2012-08-17', 'studyFirstSubmitQcDate': '2012-08-23', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Refractory Immune Thrombocytopenic Purpura', 'rapamycin', 'regulatory T cells'], 'conditions': ['Immune Thrombocytopenic Purpura']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.', 'detailedDescription': 'Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '35 patients using rapamycin therapy were observed before and after treatment,who did not response to any other administrations including prednisone and immunosuppressive drugs, even splenectomy .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnoses of idiopathic thrombocytopenic purpura\n* Hormone and immune suppression, splenectomy is invalid\n\nExclusion Criteria:\n\n* patients had a bad tolerance to rapamycin\n* platelet counts \\< 10\\*10E9/L during the treatment of rapamycin'}, 'identificationModule': {'nctId': 'NCT01672151', 'acronym': 'ITP', 'briefTitle': 'Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Suzhou Medical College'}, 'officialTitle': 'Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia', 'orgStudyIdInfo': {'id': 'jsxys456'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rapamycin', 'type': 'DRUG', 'otherNames': ['sirolimus'], 'description': '4mg oral administration on the first day, 2 mg/d oral administration for 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Institute of Hematology', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'zhaoyue wang, doctor', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Suzhou Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jiangsu Institute of hematology', 'investigatorFullName': 'Zhaoyue Wang', 'investigatorAffiliation': 'First Affiliated Hospital of Suzhou Medical College'}}}}