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

February 11, 2025 updated by: AstraZeneca
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02140
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
anti-IL-5/IL-5R therapy
Patients initiated anti-IL-5/IL-5R therapy
Other: no intervention
not applicable, this is an observational retrospective data analysis study; no interventions in the study
other therapies
Patients initiated other therapies.
Other: no intervention
not applicable, this is an observational retrospective data analysis study; no interventions in the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
01 October 2020- the most recent data available in 2023
Other eosinophilic conditions
Time Frame: 01 October 2020- the most recent data available in 2023
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
Time Frame: 01 October 2020- the most recent data available in 2023
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
Time Frame: 01 October 2020 - the most recent data available in 2023
To describe the disease burden of HES.
01 October 2020 - the most recent data available in 2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
01 October 2020- the most recent data available in 2023
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.
01 October 2020 - the most recent data available in 2023
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.
01 October 2020 - the most recent data available in 2023
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.
01 October 2020 - the most recent data available in 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3254R00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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