Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00305435
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2006-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of AMG 531 in Japanese Subjects With ITP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'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': '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'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488777', 'term': 'romiplostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2006-03-20', 'studyFirstSubmitQcDate': '2006-03-20', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of all adverse events including evaluation of antibody status', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who achieve a platelet response', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AMG 531, ITP, Phase 2, Japanese'], 'conditions': ['Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)']}, 'referencesModule': {'references': [{'pmid': '19543952', 'type': 'BACKGROUND', 'citation': 'Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Ohtsu T, Berger DP. A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura. Int J Hematol. 2009 Sep;90(2):157-165. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_46_AMP-2_20050162.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.nplate.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.', 'detailedDescription': 'The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT00305435', 'briefTitle': 'Safety Study of AMG 531 in Japanese Subjects With ITP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura', 'orgStudyIdInfo': {'id': '20050162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'romiplostim (AMG-531)', 'interventionNames': ['Drug: Romiplostim (AMG-531)']}], 'interventions': [{'name': 'Romiplostim (AMG-531)', 'type': 'DRUG', 'description': 'Romiplostim (AMG-531)', 'armGroupLabels': ['romiplostim (AMG-531)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}