Status:
COMPLETED
A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
Lead Sponsor:
Takeda
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
12+ years
Brief Summary
The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free ...
Eligibility Criteria
Inclusion
- Participant is aged \>= 12 years at the time of the last documented HAE attack in the eligibility period.
- 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
- Participant was enrolled in a therapeutic investigational drug or device trial during the observation period.
- 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.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04861090
Start Date
September 15 2021
End Date
June 30 2022
Last Update
January 13 2023
Active Locations (20)
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1
LKH-Universitätsklinikum Klinikum Graz
Graz, Austria, 8036
2
Kepler Universitätsklinikum Linz
Linz, Austria, 4021
3
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, Austria, 1090
4
CHU de Grenoble
Grenoble, France, 38043