TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause

Completed

• Conditions: Hypereosinophilic Syndrome (HES)
• Interventions: Other: no intervention

• Registration Number: NCT06172751
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study Start: 2023-12-15
• Study First Posted: 2023-12-15
• Primary Completion: 2024-04-26
• Study Completion: 2024-04-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anti-IL-5/IL-5R therapy	no intervention	Patients initiated anti-IL-5/IL-5R therapy
other therapies	no intervention	Patients initiated other therapies.

Primary Outcome Measures

Name	Time	Method
Comorbidities prior to first HES record	01 October 2020- the most recent data available in 2023	To describe clinical characteristics of patients with HES.
Number of organ systems with HES signs and/or symptoms	01 October 2020 - the most recent data available in 2023	To describe the disease burden of HES.
Other eosinophilic conditions	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	01 October 2020- the most recent data available in 2023	To describe the disease burden of HES.

Secondary Outcome Measures

Name	Time	Method
Demographic characteristics	01 October 2020- the most recent data available in 2023	To describe the demographic characteristics of HES patients and sub-group analysis patients.
HES and non-HES therapies & treatment pattern	01 October 2020 - the most recent data available in 2023	To describe the treatment pattern of HES patients and sub-group analysis patients.
Patient journey in diagnostic phase	01 October 2020 - the most recent data available in 2023	To describe the patient journey in diagnostic phase and in sub-group analysis.
Clinical outcomes	01 October 2020 - the most recent data available in 2023	To describe clinical outcome pre and post index date and compare between biologics and patients treated with anti-IL-5/IL-5Rα therapies.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Cambridge, Massachusetts, United States