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)

Documents

Study protocol

Updated protocol

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

First published: 16/07/2024

Study results

No information provided.

Study report

No information provided.

Publications

Study publications

Lee A. Berotralstat: First Approval. Drugs. 2021 Feb;81:405-9.

Bork K, Hardt J, Witzke G. Fatal laryngeal attacks and mortality in hereditary …

Longhurst H, Cicardi M. Hereditary angio-oedema. The Lancet. 2012 Feb 4;379(981…

Aygören-Pürsün E, Bygum A, Grivcheva-Panovska V, Magerl M, Graff J, Steiner UC,…

Lumry WR, Castaldo AJ, Vernon MK, Blaustein MB, Wilson DA, Horn PT. The humanis…

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

No information provided.