HAE Burden and Crisis Management

NCT06806618 | Completed

• 1 other identifier: 3824.0394
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hereditary Angioedema (HAE)

Keywords

survey; on-demand treatment; hereditary angioedema; burden; caregivers; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Patients with HAE

Patients will complete an online survey.

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: All patients, irrespective of their gender are eligible for the study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HAE

You may qualify if:

• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: March 1, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 29, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)