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Clinical Trial Summary

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.


Clinical Trial Description

APeX-A, 7353-312, is a single-arm, open-label, multicenter study. The study will be conducted in countries where berotralstat is not available either commercially or via another mechanism. All enrolled subjects will receive the planned marketed dose of berotralstat, 150 mg QD. The study will assess the long term safety and tolerability of berotralstat. Eligible subjects will be enrolled directly into Study BCX7353-312 (Study 312) from Studies 302 and 204. Subjects will receive berotralstat 150 mg administered orally once daily (QD). Subjects will return to the clinic every 24 weeks for drug dispensation and safety monitoring for up to 240 weeks (approximately 5 years). Safety and tolerability will be evaluated through assessment of serious adverse events (SAEs) and treatment-related, treatment-emergent adverse events (TEAEs). Up to 110 subjects are planned to enroll. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04933721
Study type Interventional
Source BioCryst Pharmaceuticals
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 23, 2021
Completion date August 2026

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