A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
NCT ID: NCT04861090
Last Updated: 2023-01-13
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
207 participants
OBSERVATIONAL
2021-09-15
2022-06-30
Brief Summary
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This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study.
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 Hereditary Angioedema
Participants with HAE type I or type II who had initiated long-term prophylaxis (LTP) treatment with lanadelumab which was administered every two weeks (Q2W) or every four weeks (Q4W) or every six weeks (Q6W) or every eight weeks (Q8W) in accordance to Summary of Product Characteristics (SmPC), during a routine clinical setting will be followed up to 38 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II.
* Participant had initiated LTP with lanadelumab during the eligibility period.
* Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations).
Exclusion Criteria
* Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.
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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LKH-Universitätsklinikum Klinikum Graz
Graz, , Austria
Kepler Universitätsklinikum Linz
Linz, , Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, , Austria
CHU de Grenoble
Grenoble, , France
CHRU Lille
Lille, , France
Groupement Hospitalier Edouard Herriot
Lyon, , France
CHU Montpellier - Hôpital St Eloi
Montpellier, , France
Hôtel Dieu de Paris Hospital
Paris, , France
Hôpital Saint Antoine
Paris, , France
Centre Hospitalier Universitaire Hopitaux de Rouen
Rouen, , France
Charitè Campus Mitte
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Hämophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, , Germany
Klinikum rechts der Isa der Technischen Universitaet Muenchen
Munich, , Germany
Universitatsklinikum Munster
Münster, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Navy Hospital of Athens
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
Countries
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References
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Magerl M, Bouillet L, Martinez-Saguer I, Gavini F, Bent-Ennakhil N, Sayegh L, Andresen I. Real-World Effectiveness of Lanadelumab in Hereditary Angioedema: Multicountry INTEGRATED Observational Study. J Allergy Clin Immunol Pract. 2025 Feb;13(2):378-387.e2. doi: 10.1016/j.jaip.2024.12.008. Epub 2024 Dec 17.
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-2020-081002
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-743-4006
Identifier Type: -
Identifier Source: org_study_id
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