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  2. Non-Interventional Post-Authorisation Study to Evaluate the Safety, Tolerability and Effectiveness of Berotralstat for Patients with Hereditary Angioedema (HAE) in a Real-World Setting (APeX-N)

Non-Interventional Post-Authorisation Study to Evaluate the Safety, Tolerability and Effectiveness of Berotralstat for Patients with Hereditary Angioedema (HAE) in a Real-World Setting (APeX-N)

08/10/2021
16/07/2024
EU PAS number:
EUPAS43575
Study
Ongoing
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Study protocol
Updated protocol

BCX7353-401 Protocol v3.0_Redacted_10 Jul 2024.pdf

First published: 16/07/2024
English (11.17 MB - PDF)View document
Study results
Study report
Other information
Publications
Study publications
Lee A. Berotralstat: First Approval. Drugs. 2021 Feb;81:405-9.(link is external)
Bork K, Hardt J, Witzke G. Fatal laryngeal attacks and mortality in hereditary …(link is external)
Longhurst H, Cicardi M. Hereditary angio-oedema. The Lancet. 2012 Feb 4;379(981…(link is external)
Aygören-Pürsün E, Bygum A, Grivcheva-Panovska V, Magerl M, Graff J, Steiner UC,…(link is external)
Lumry WR, Castaldo AJ, Vernon MK, Blaustein MB, Wilson DA, Horn PT. The humanis…(link is external)

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