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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06007677 -
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
|
Phase 2 | |
Completed |
NCT00997204 -
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
|
Phase 3 | |
Completed |
NCT00438815 -
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
|
Phase 3 | |
Completed |
NCT00748202 -
Berinert P Study of Subcutaneous Versus Intravenous Administration
|
Phase 3 | |
Completed |
NCT01426763 -
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
|
Phase 2 | |
Terminated |
NCT04091113 -
Hereditary Angioedema Kininogen Assay
|
||
Completed |
NCT00432510 -
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
|
Phase 1 | |
Completed |
NCT03712228 -
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
|
Phase 2 | |
Active, not recruiting |
NCT05453968 -
Berotralstat Treatment in Children With Hereditary Angioedema
|
Phase 3 | |
Recruiting |
NCT05511922 -
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
|
Phase 3 | |
Recruiting |
NCT05505916 -
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
|
Phase 3 | |
Not yet recruiting |
NCT02159430 -
Hereditary AngioEdema, Neurobiology and Psychopathology
|
N/A | |
Completed |
NCT02303626 -
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
|
Phase 2/Phase 3 | |
Completed |
NCT01984788 -
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
|
Phase 2 | |
Completed |
NCT02448264 -
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
|
Phase 1 | |
Completed |
NCT05118958 -
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
|
Phase 1 | |
Completed |
NCT06414252 -
Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
|
||
Active, not recruiting |
NCT04739059 -
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
|
Phase 3 | |
Completed |
NCT02819102 -
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
|
Phase 1 | |
Completed |
NCT01679912 -
A Call Center During HAE Attacks (SOS HAE)
|
Phase 4 |