HAE Burden and Crisis Management (ECRINS)

April 28, 2026 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • France
      • Grenoble, France
        • CHU Grenoble Alpes

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with HAE

Description

Inclusion Criteria:

For the patient population:

  1. Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.
  2. Aged ≥12 years
  3. 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.)

Exclusion Criteria:

For the patient population:

  1. Opposes to participating in the study.
  2. Patients is under guardianship or deprived of their liberty.

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
Patients with HAE
Patients will complete an online survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The survey will focus on HAE attacks that have occurred within the last 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
The survey will focus on HAE attacks that have occurred within the last 12 months.

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

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)

March 1, 2025

Primary Completion (Actual)

August 25, 2025

Study Completion (Actual)

August 29, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3824.0394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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