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

Hypereosinophilic Syndrome (HES) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06172751
• Other study ID #: D3254R00004
• Status: Completed
• Start date: December 15, 2023
• Est. completion date: April 26, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 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)

Related Conditions & MeSH terms

• Hypereosinophilic Syndrome
• Hypereosinophilic Syndrome (HES)
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

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