Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00451594
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2007-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D011239', 'term': 'Prednisolone'}], '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': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-12', 'studyFirstSubmitDate': '2007-03-22', 'studyFirstSubmitQcDate': '2007-03-22', 'lastUpdatePostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate and platelet count', 'timeFrame': '6 years', 'description': 'Endpoint definitions and criteria for evaluation: This study is designed to compare the effectiveness of high dose dexamethasone with conventional dose prednisone for patient with ITP. The effectiveness will be evaluated in terms of response rate and platelet count at 6 months after the treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ITP'], 'conditions': ['Idiopathic Thrombocytopenic Purpura']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.google.co.kr', 'label': 'A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURA'}]}, 'descriptionModule': {'briefSummary': 'To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.', 'detailedDescription': 'Patients will be randomized to one of two study arms:\n\ndexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).\n\nPrednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* a true thrombocytopenia on blood smear\n* adequate megakaryopoiesis on bone marrow examination\n* the absence of clinically apparent associated conditions or cause of thrombocytopenia\n* Age over 16 years\n* A platelet count of less than 30x109/L\n\nExclusion criteria :\n\n* previous treatment for ITP.\n* other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.\n* Patients with life threatening bleeding and pregnant women should be excluded.'}, 'identificationModule': {'nctId': 'NCT00451594', 'briefTitle': 'High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP', 'organization': {'class': 'NETWORK', 'fullName': 'Cooperative Study Group A for Hematology'}, 'officialTitle': 'A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura', 'orgStudyIdInfo': {'id': 'C-009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexa'], 'description': 'Pulse high dose dexamethasone (Arm 1)\n\n1. Patients will receive 40 mg of oral dexamethasone daily for four consecutive days.\n2. Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14\n3. If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given.\n4. If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering.\n5. Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments.'}, {'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['PD'], 'description': 'Conventional dose prednisone (Arm 2)\n\n1. Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter.\n2. Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung Hwa Bae, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic Univertity Hospital, ROK'}, {'name': 'Jung-Hee Lee, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, ROK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperative Study Group A for Hematology', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'COSAH', 'oldOrganization': 'Cooperative Study Group A for Hematology'}}}}