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Completed

NCT Number: NCT06806618

HAE Burden and Crisis Management

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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 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:

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Survey Evaluating the Burden and Management of HAE Crises by Patients and Caregivers

Acronym: ECRINS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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