Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06172751
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}], 'ancestors': [{'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comorbidities prior to first HES record', 'timeFrame': '01 October 2020- the most recent data available in 2023', 'description': 'To describe clinical characteristics of patients with HES.'}, {'measure': 'Other eosinophilic conditions', 'timeFrame': '01 October 2020- the most recent data available in 2023', 'description': 'To describe the clinical characteristics of HES patients.'}, {'measure': 'Organ system with HES signs and/or symptoms', 'timeFrame': '01 October 2020- the most recent data available in 2023', 'description': 'To describe the disease burden of HES.'}, {'measure': 'Number of organ systems with HES signs and/or symptoms', 'timeFrame': '01 October 2020 - the most recent data available in 2023', 'description': 'To describe the disease burden of HES.'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics', 'timeFrame': '01 October 2020- the most recent data available in 2023', 'description': 'To describe the demographic characteristics of HES patients and sub-group analysis patients.'}, {'measure': 'Patient journey in diagnostic phase', 'timeFrame': '01 October 2020 - the most recent data available in 2023', 'description': 'To describe the patient journey in diagnostic phase and in sub-group analysis.'}, {'measure': 'HES and non-HES therapies & treatment pattern', 'timeFrame': '01 October 2020 - the most recent data available in 2023', 'description': 'To describe the treatment pattern of HES patients and sub-group analysis patients.'}, {'measure': 'Clinical outcomes', 'timeFrame': '01 October 2020 - the most recent data available in 2023', 'description': 'To describe clinical outcome pre and post index date and compare between biologics and patients treated with anti-IL-5/IL-5Rα therapies.'}]}, 'conditionsModule': {'conditions': ['Hypereosinophilic Syndrome (HES)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3254R00004&attachmentIdentifier=937528c6-d4bf-4827-9f4c-53e440c1668c&fileName=D3254R00004_AZ_TriNetX_HES_study_report_synopsis_redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.', 'detailedDescription': 'Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis record of HES (ICD-10-CM D72.11) anytime during 01 October 2020 to 30 June 2023\n* At least 12 months of patient insurance record prior to first HES record.\n\nExclusion Criteria:\n\n* Any mutation in PDGFRA, PDGFRB or FGFR1 genes (to exclude clonal HES).\n* History of BCR-ABL tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal HES)\n* History of myeloid leukemia, myeloproliferative disorder, myelodysplastic disorder, myelomonocytic leukemia, acute erythroid leukemia, acute megakaryoblastic leukaemia, acute panmyelosis with myelofibrosis, and other specified leukaemias (to exclude reactive HES)\n* History of helminthiasis or use of anthelmintic medication (to exclude reactive HES)\n* History of autoimmune disease (to exclude reactive HES)\n* History of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive HES)'}, 'identificationModule': {'nctId': 'NCT06172751', 'briefTitle': 'TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause', 'orgStudyIdInfo': {'id': 'D3254R00004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anti-IL-5/IL-5R therapy', 'description': 'Patients initiated anti-IL-5/IL-5R therapy', 'interventionNames': ['Other: no intervention']}, {'label': 'other therapies', 'description': 'Patients initiated other therapies.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'not applicable, this is an observational retrospective data analysis study; no interventions in the study', 'armGroupLabels': ['anti-IL-5/IL-5R therapy']}, {'name': 'no intervention', 'type': 'OTHER', 'description': 'not applicable, this is an observational retrospective data analysis study; no interventions in the study', 'armGroupLabels': ['other therapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02140', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}