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

NCT06172751 | Completed

• 1 other identifier: D3254R00004
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.

Conditions

Hypereosinophilic Syndrome (HES)

Outcome Measures

Primary Outcomes (4)

• Comorbidities prior to first HES record

  To describe clinical characteristics of patients with HES.

  01 October 2020- the most recent data available in 2023

• Other eosinophilic conditions

  To describe the clinical characteristics of HES patients.

  01 October 2020- the most recent data available in 2023

• 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

• 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 Outcomes (4)

• 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

• HES and non-HES therapies & treatment pattern

  01 October 2020 - the most recent data available in 2023

• Clinical outcomes

  01 October 2020 - the most recent data available in 2023

Study Arms (2)

anti-IL-5/IL-5R therapy

Patients initiated anti-IL-5/IL-5R therapy

Other: no intervention

other therapies

Patients initiated other therapies.

Other: no intervention

Interventions

no intervention OTHER

not applicable, this is an observational retrospective data analysis study; no interventions in the study

anti-IL-5/IL-5R therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Cambridge, Massachusetts, 02140, United States

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Hypereosinophilic Syndrome

Condition Hierarchy (Ancestors)

Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: December 15, 2023
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)