Hereditary Angioedema Clinical Trial
— BESQAOHOfficial title:
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
| NCT number | NCT04888650 |
| Other study ID # | 38RC21.054 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 3, 2021 |
| Est. completion date | January 2, 2022 |
| Verified date | April 2021 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec. Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)
| Status | Completed |
| Enrollment | 314 |
| Est. completion date | January 2, 2022 |
| Est. primary completion date | January 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patient with HAE with or without C1 inhibitor deficiency - Patient over 15 or parents of a child under 15 with HAE Exclusion Criteria: - Patient opposed to the use of their data or refusing to answer the questionnaire - Adult patients protected by law |
| Country | Name | City | State |
|---|---|---|---|
| France | CHUGA | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE) | questionnaire To know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE) | baseline | |
| Secondary | comparaison of results with quebec | Comparison of the results of the French questionnaire, only the questions adapted from the Quebec questionnaire, with the results of the Quebec survey conducted by Jean-Nicolas Boursiquot in 2018. | baseline |
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