A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema
NCT ID: NCT04957641
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
221 participants
OBSERVATIONAL
2022-04-21
2023-01-13
Brief Summary
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The main aims of this study are as follows:
* to learn how often, how severe and where on the body HAE attacks occur.
* to describe how HAE prophylaxis and on-demand medicines are prescribed and used. (Prophylaxis medicines prevent a bleed from happening and on-demand medicines treat a bleed when it occurs.)
This study is about collecting data only; participants will not receive treatment as part of this study. Existing data available in the participant's medical records will be collected. Participants will be asked to complete an electronic questionnaire either on a website or by using an app on their mobile phone; data from this questionnaire will also be collected.
Participants do not need to visit their doctor in addition to their normal visits.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants with HAE
Participants' data will be collected retrospectively from electronic medical records using chart review of de-identified data on participant demographics, HAE medical history and information on diagnostics, treatments and disease course assessments that are routinely performed in accordance with current guidelines and/or local standard of care which are entered into an Electronic data capture (EDC) system over multiple data collection waves up to 6 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II.
* Participant had at least one documented HAE attack during the eligibility period.
* Participant is not adequately or sub-optimally controlled according to treating physician.
* Participant (or parent/legal guardian) is willing and able to comply with the study requirements and provides informed consent or assent.
Exclusion Criteria
* Participant initiated long-term prophylaxis with Takhzyro® at any time since diagnosis.
12 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Medizinische Universitat Wien (Medical University of Vienna)
Vienna, , Austria
UZ Antwerpen
Edegem, , Belgium
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, , Bulgaria
Vancouver Allergy Clinic
Vancouver, British Columbia, Canada
McMaster University Medical Centre
Hamilton, , Canada
General Hospital Sibenik
Šibenik, , Croatia
Klinicki bolnicki centar Zagreb
Zagreb, , Croatia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
East Tallinn Central Hospital
Tallinn, , Estonia
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Navy Hospital of Athens
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
Semmelweis Egyetem
Budapest, , Hungary
St James's Hospital
Dublin, , Ireland
Barzilai Medical Center
Ashkelon, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Centre of Investigation and Treatment of Allergic Diseases
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Medical Faculty of Ss. Cyril and Methodius Univers
Skopje, , North Macedonia
Wojskowy Instytut Medyczny
Warsaw, , Poland
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar de São João, E.P.E.
Porto, , Portugal
MediQuest Clinical Research Center
Sângeorgiu de Mures, , Romania
University Clinical Center of Serbia - PPDS
Belgrade, , Serbia
Univerzitna nemocnica Martin
Martin, , Slovakia
Bolnisnica Golnik - Klinicni Oddelek za Pljucne Bolezni In Alergijo
Golnik, , Slovenia
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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References
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Farkas H, Aygoren-Pursun E, Ebo DG, Bara N, Psarros F, Gavini F, Bent-Ennakhil N, Sayegh L, Andresen I. Real-world treatment patterns and burden-of-disease of sub-optimally controlled hereditary angioedema. World Allergy Organ J. 2025 Sep 1;18(9):101100. doi: 10.1016/j.waojou.2025.101100. eCollection 2025 Sep.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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MACS-2020-080401
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-743-4009
Identifier Type: -
Identifier Source: org_study_id
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