APeX-N NI-PASS evaluating Berotralstat in a real-world setting

• Research type

  Research Study

• Full title

  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

• IRAS ID

  310778

• Contact name

  Zlatko Sisic

• Contact email

  zsisic@biocryst.com

• Sponsor organisation

  BioCryst Ireland Limited

• Clinicaltrials.gov Identifier

  EUPAS43575, ENCePP

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  The aim of this study is to monitor the long term safety, tolerability and effectiveness of berotralstat in adult and adolescent patients with Hereditary angioedema (HAE). Berotralstat has been granted marketing approval in the UK and this non-interventional post authorisation safety study (NI PASS) is designed to collect data on the use of berotralstat in a real world setting.

  Patients will attend their routine visits inline with their standard clinical practice. Data will be collected during these routine visits in the patients medical records and used to further determine the safety profile of berotralstat together with an assessment of the quality of life during long term treatment and growth in adolescents.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  22/NW/0068

• Date of REC Opinion

  22 Mar 2022

• REC opinion

  Further Information Favourable Opinion