A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
NCT ID: NCT04130191
Last Updated: 2025-09-02
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
140 participants
OBSERVATIONAL
2019-12-11
2024-09-09
Brief Summary
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Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with hereditary angioedema (HAE)
Participants who initiate treatment with lanadelumab according to current product labelling will be enrolled and followed for up to 24 or 36 months (depending on their enrollment date).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Initiation of treatment with lanadelumab in accordance with current product labelling. Decision to start treatment with lanadelumab must be made before and be independent from enrollment in the study.
* Availability of information for HAE attack-related variables assessed at study enrollment for the previous three months.
* Ability to use a smartphone for data collection in this study.
Exclusion Criteria
* Participation in the study not considered appropriate by the treating physician/investigator.
* Contraindication to treatment with lanadelumab according to current product labelling.
* Pregnant or breastfeeding.
* Concomitant exposure to any investigational therapy (including medications not used for HAE).
* Current or planned participation in other interventional studies.
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Medical University of Vienna
Vienna, , Austria
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitatsklinikum Dusseldorf
Düsseldorf, , Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, , Germany
Hämophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Bnai Zion Medical Center
Haifa, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, , Italy
Azienda Ospedale Università Padova
Padua, , Italy
Al-Rashed Allergy Center
Kuwait City, , Kuwait
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Universitätsspital Basel
Basel, , Switzerland
Luzerner Kantonsspital LUKS
Lucerne, , Switzerland
Countries
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References
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Zanichelli A, Wuillemin WA, Aygoren-Pursun E, Banerji A, Busse PJ, Betschel SD, Cancian M, Gagnon R, Goodyear MD, Kinaciyan T, Kessel A, Magerl M, Recke A, Wedner HJ, Estepan DN, Watt M, Andresen I, Juethner S, Khutoryansky N, Martinez-Saguer I. Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence. Ann Allergy Asthma Immunol. 2025 Sep 5:S1081-1206(25)00393-X. doi: 10.1016/j.anai.2025.07.025. Online ahead of print.
Tachdjian R, Banerji A, Busse PJ, Agmon-Levin N, Anderson J, Cancian M, Spadaro G, Enciu C, Estepan DN, Khutoryansky N, Jain S, Recke A. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE. Pediatr Allergy Immunol. 2025 Apr;36(4):e70072. doi: 10.1111/pai.70072.
Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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TAK-743-402
Identifier Type: OTHER
Identifier Source: secondary_id
SHP643-402
Identifier Type: -
Identifier Source: org_study_id
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