Hypereosinophilic Syndrome (HES) Clinical Trial
Official title:
TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
| NCT number | NCT06172751 |
| Other study ID # | D3254R00004 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 15, 2023 |
| Est. completion date | May 1, 2024 |
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.
| Status | Recruiting |
| Enrollment | 250 |
| Est. completion date | May 1, 2024 |
| Est. primary completion date | May 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Cambridge | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comorbidities prior to first HES record | To describe clinical characteristics of patients with HES. | 01 October 2020- the most recent data available in 2023 | |
| Primary | Other eosinophilic conditions | To describe the clinical characteristics of HES patients. | 01 October 2020- the most recent data available in 2023 | |
| Primary | Organ system with HES signs and/or symptoms | To describe the disease burden of HES. | 01 October 2020- the most recent data available in 2023 | |
| Primary | Number of organ systems with HES signs and/or symptoms | To describe the disease burden of HES. | 01 October 2020 - the most recent data available in 2023 | |
| Secondary | Demographic characteristics | To describe the demographic characteristics of HES patients and sub-group analysis patients. | 01 October 2020- the most recent data available in 2023 | |
| Secondary | Patient journey in diagnostic phase | To describe the patient journey in diagnostic phase and in sub-group analysis. | 01 October 2020 - the most recent data available in 2023 | |
| Secondary | HES and non-HES therapies & treatment pattern | To describe the treatment pattern of HES patients and sub-group analysis patients. | 01 October 2020 - the most recent data available in 2023 | |
| Secondary | Clinical outcomes | To describe clinical outcome pre and post index date and compare between biologics and patients treated with anti-IL-5/IL-5Ra therapies. | 01 October 2020 - the most recent data available in 2023 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| No longer available |
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