Hypereosinophilic Syndrome (HES)NCT06172751
TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
An observational study of Hypereosinophilic Syndrome (HES), run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypereosinophilic Syndrome (HES)
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 26 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.
Read the detailed description
Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.
- Conditions
- Hypereosinophilic Syndrome (HES)
- Being tested
- no intervention
- Medical subject headings
- Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
not applicable, this is an observational retrospective data analysis study; no interventions in the study
no interventionOther
not applicable, this is an observational retrospective data analysis study; no interventions in the study
| Study group | Role | What they receive |
|---|---|---|
| anti-IL-5/IL-5R therapy | Patients initiated anti-IL-5/IL-5R therapy Receives: Other: no intervention | |
| other therapies | Patients initiated other therapies. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comorbidities prior to first HES record
To describe clinical characteristics of patients with HES.
Measured: 01 October 2020- the most recent data available in 2023
Other eosinophilic conditions
To describe the clinical characteristics of HES patients.
Measured: 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.
Measured: 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.
Measured: 01 October 2020 - the most recent data available in 2023
Secondary outcomes (4)
Demographic characteristics
To describe the demographic characteristics of HES patients and sub-group analysis patients.
Measured: 01 October 2020- the most recent data available in 2023
Patient journey in diagnostic phase
To describe the patient journey in diagnostic phase and in sub-group analysis.
Measured: 01 October 2020 - the most recent data available in 2023
HES and non-HES therapies & treatment pattern
To describe the treatment pattern of HES patients and sub-group analysis patients.
Measured: 01 October 2020 - the most recent data available in 2023
Clinical outcomes
To describe clinical outcome pre and post index date and compare between biologics and patients treated with anti-IL-5/IL-5Rα therapies.
Measured: 01 October 2020 - the most recent data available in 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Dec 2023
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypereosinophilic Syndrome (HES)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172751
- Sponsor's protocol ID
- D3254R00004
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
- ClinicalTrials.gov ID
- NCT06172751
- Acronym / sponsor ID
- D3254R00004
- Conditions
- Hypereosinophilic Syndrome (HES)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-IL-5/IL-5R therapy | – | Other: no interventionPatients initiated anti-IL-5/IL-5R therapy |
| other therapies | – | Other: no interventionPatients initiated other therapies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionnot applicable, this is an observational retrospective data analysis study; no interventions in the study | Other | anti-IL-5/IL-5R therapy |
| no interventionnot applicable, this is an observational retrospective data analysis study; no interventions in the study | Other | other therapies |
Primary outcome
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.
Other eosinophilic conditions
Time frame: 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
Time frame: 01 October 2020- the most recent data available in 2023
To describe the disease burden of HES.
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.
4 secondary outcomes
Demographic characteristics
Time frame: 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
HES and non-HES therapies & treatment pattern
Time frame: 01 October 2020 - the most recent data available in 2023
Clinical outcomes
Time frame: 01 October 2020 - the most recent data available in 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypereosinophilic Syndrome (HES), run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comorbidities prior to first HES record (time frame: 01 October 2020- the most recent data available in 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.