TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Comorbidities prior to first HES record
Study Overview
Brief Summary
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.
Detailed Description
Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis record of HES (ICD-10-CM D72.11) anytime during 01 October 2020 to 30 June 2023
- •At least 12 months of patient insurance record prior to first HES record.
Exclusion Criteria
- •Any mutation in PDGFRA, PDGFRB or FGFR1 genes (to exclude clonal HES).
- •History of BCR-ABL tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal HES)
- •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)
- •History of helminthiasis or use of anthelmintic medication (to exclude reactive HES)
- •History of autoimmune disease (to exclude reactive HES)
- •History of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive HES)
Outcomes
Primary Outcomes
Comorbidities prior to first HES record
Time Frame: 01 October 2020- the most recent data available in 2023
To describe clinical characteristics of patients with HES.
Other eosinophilic conditions
Time Frame: 01 October 2020- the most recent data available in 2023
To describe the clinical characteristics of HES patients.
Organ system with HES signs and/or symptoms
Time Frame: 01 October 2020- the most recent data available in 2023
To describe the disease burden of HES.
Number of organ systems with HES signs and/or symptoms
Time Frame: 01 October 2020 - the most recent data available in 2023
To describe the disease burden of HES.
Secondary Outcomes
- HES and non-HES therapies & treatment pattern(01 October 2020 - the most recent data available in 2023)
- Demographic characteristics(01 October 2020- the most recent data available in 2023)
- Patient journey in diagnostic phase(01 October 2020 - the most recent data available in 2023)
- Clinical outcomes(01 October 2020 - the most recent data available in 2023)