Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
← catalyst calendarNCT04933721 · readout ≤ 1,838 d
Sponsored by BioCryst Pharmaceuticals (industry) · BCRX — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Prevention
Enrollment
139estimated
Sites
16
Countries
Canada, Czechia, France +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-07-23 | actual | When the study began enrolling |
| Primary completion | Aug 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2021-06-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hereditary Angioedema
- HAE
Intervention
- Drug: berotralstat — also filed as Orladeyo
Primary outcomes
what the primary-completion date above is the date OFNumber and proportion of subjects with a treatment-related TEAE
measured 240 weeks
Number and proportion of subjects who experience a serious adverse event (SAE)
measured 240 weeks
Number and proportion of subjects who experience a treatment-related Grade 3 or 4 TEAE
measured 240 weeks
Number and proportion of subjects who experience a treatment-related Grade 3 or 4 treatment-emergent chemistry abnormality
measured 240 weeks
Number and proportion of subjects who discontinue due to a TEAE
measured 240 weeks
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