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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
electronic questionnaire

Locations

Country Name City State
France CHUGA Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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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