Hereditary Angioedema (HAE)ECRINSNCT06806618
HAE Burden and Crisis Management
An observational study of Hereditary Angioedema (HAE), run by University Hospital, Grenoble at 1 site in France.
Trial summary
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 29 Aug 2025
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HAE
Who may be able to join
- For the patient population:
- Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.
- Aged ≥12 years
- Having consulted for HAE in the last 3 months and with a medical file.
- For the caregiver population:
- 1. A person identified by the patient as part of their support group and who provides support with the management of the patients HAE (including family members, friends, spouse, etc.)
Who cannot join
- For the patient population:
- Opposes to participating in the study.
- Patients is under guardianship or deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey Evaluating the Burden and Management of HAE Crises by Patients and Caregivers
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives.
Read the detailed description
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- survey, on-demand treatment, hereditary angioedema, burden, caregivers, quality of life
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HAE | Patients will complete an online survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the burden associated with the on-demand treatment of HAE attacks
The burden associated with the on-demand treatment of HAE attacks from the patient's and caregiver's perspective, will be described in terms of:
- The frequency of HAE attacks.
- The severity of HAE attacks.
- Disease control.
- Events that trigger the HAE attacks.
- Frequency of injections for treating HAE attacks.
- Delay in injections for treating HAE attacks.
- Hospitalization for HAE attacks.
- Impact on quality of life (during HAE attacks).
- Impact on quality of life (between HAE attacks).
- Social impact.
- Financial impact.
- Burden of the caregivers.
Measured: The survey will focus on HAE attacks that have occurred within the last 12 months.
Secondary outcomes (1)
Use of on-demand treatments for HAE attacks
The survey will collect data to for the following:
- To estimate the number of patients that delay or do not use injectable on-demand treatments for HAE.
- To identify the reasons why patients, delay or do not use injectable on-demand treatments for HAE attacks.
- To study the potential benefits of introducing an oral on-demand treatment for HAE attacks.
Measured: The survey will focus on HAE attacks that have occurred within the last 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Mar 2025
- Primary completion25 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806618
- Sponsor's protocol ID
- 3824.0394
- Acronym
- ECRINS
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey Evaluating the Burden and Management of HAE Crises by Patients and Caregivers
- ClinicalTrials.gov ID
- NCT06806618
- Acronym / sponsor ID
- ECRINS / 3824.0394
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- survey, on-demand treatment, hereditary angioedema, burden, caregivers, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 4 Feb 2025 (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 study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives.
Detailed description
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HAE | – | –Patients will complete an online survey. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HAE
Key inclusion criteria (6 listed)
- Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.
- Aged ≥12 years
- Having consulted for HAE in the last 3 months and with a medical file.
- 1. A person identified by the patient as part of their support group and who provides support with the management of the patients HAE (including family members, friends, spouse, etc.)
Key exclusion criteria (3 listed)
- Opposes to participating in the study.
- Patients is under guardianship or deprived of their liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the burden associated with the on-demand treatment of HAE attacks
Time frame: The survey will focus on HAE attacks that have occurred within the last 12 months.
The burden associated with the on-demand treatment of HAE attacks from the patient's and caregiver's perspective, will be described in terms of: * The frequency of HAE attacks. * The severity of HAE attacks. * Disease control. * Events that trigger the HAE attacks. * Frequency of injections for treating HAE attacks. * Delay in injections for treating HAE attacks. * Hospitalization for HAE attacks. * Impact on quality of life (during HAE attacks). * Impact on quality of life (between HAE attacks). * Social impact. * Financial impact. * Burden of the caregivers.
1 secondary outcome
Use of on-demand treatments for HAE attacks
Time frame: The survey will focus on HAE attacks that have occurred within the last 12 months.
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable request.
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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 Hereditary Angioedema (HAE), run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 3 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 29 Apr 2026. 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 France. 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?
To describe the burden associated with the on-demand treatment of HAE attacks (time frame: The survey will focus on HAE attacks that have occurred within the last 12 months.). 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 29 Apr 2026.