Status:
COMPLETED
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
Lead Sponsor:
Shire
Collaborating Sponsors:
Takeda Development Center Americas, Inc.
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
Brief Summary
The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started. Data from participant...
Eligibility Criteria
Inclusion
- Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study.
- 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
- Inability to provide written, signed, and dated informed consent.
- 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.
Key Trial Info
Start Date :
December 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04130191
Start Date
December 11 2019
End Date
September 9 2024
Last Update
September 2 2025
Active Locations (19)
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1
Medical University of Vienna
Vienna, Austria, 1090
2
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany, 60590
3
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
4
Universitatsklinikum Dusseldorf
Düsseldorf, Germany, 40225