Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-06 @ 10:20 PM
Study NCT ID:
NCT03363334
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-08-01
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory 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': 'C523665', 'term': 'fostamatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2018-06', 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['ITP', 'Immune Thrombocytopenia'], 'conditions': ['Immune Thrombocytopenic Purpura']}, 'descriptionModule': {'briefSummary': 'C-935788-055 is an open-label, multi-center, expanded access (EAP) study.', 'detailedDescription': 'The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patient with chronic or persistent ITP.\n2. Must have failed or are unable to receive standard of care treatments for ITP.\n3. Must have at least two platelet counts \\< 30,000/µL during the last 2 months prior to screen date.\n\nExclusion Criteria:\n\n1. ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.\n2. Subject has uncontrolled or poorly controlled hypertension.\n3. Any of the following laboratory abnormalities: neutrophil count of \\< 1,500/µL, or transaminase levels (ALT, AST) \\> 1.5x ULN, total bilirubin \\> 2.0 mg/dL.\n4. Active HBV or HCV infection.\n5. Current or recent enrollment in an investigational drug or device study.'}, 'identificationModule': {'nctId': 'NCT03363334', 'briefTitle': 'Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rigel Pharmaceuticals'}, 'officialTitle': 'Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)', 'orgStudyIdInfo': {'id': 'C-935788-055'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fostamatinib disodium 100 mg', 'type': 'DRUG', 'otherNames': ['Fostamatinib', 'R935788', 'R788'], 'description': 'Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)'}, {'name': 'Fostamatinib disodium 150 mg', 'type': 'DRUG', 'otherNames': ['Fostamatinib', 'R935788', 'R788'], 'description': 'Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne-Marie Duliege, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigel Pharmaceuticals, Inc., Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}