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OpenTrials
Completed

NCT Number: NCT06172751

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Cambridge, Massachusetts, 02140, United States

About this study

Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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.

  2. Other eosinophilic conditions

    Time frame: 01 October 2020- the most recent data available in 2023

    To describe the clinical characteristics of HES patients.

  3. 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.

  4. 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

  1. Demographic characteristics

    Time frame: 01 October 2020- the most recent data available in 2023

    To describe the demographic characteristics of HES patients and sub-group analysis patients.

  2. Patient journey in diagnostic phase

    Time frame: 01 October 2020 - the most recent data available in 2023

    To describe the patient journey in diagnostic phase and in sub-group analysis.

  3. HES and non-HES therapies & treatment pattern

    Time frame: 01 October 2020 - the most recent data available in 2023

    To describe the treatment pattern of HES patients and sub-group analysis patients.

  4. Clinical outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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