Berotralstat Treatment in Children With Hereditary Angioedema
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Prevention
Enrollment
29actual
Sites
15
Countries
Austria, Canada, France +7
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 | 2022-10-25 | actual | When the study began enrolling |
| Primary completion | 2024-09-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-12 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-25 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-25 | 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
- Pediatric
Intervention
- Drug: Berotralstat — also filed as BCX7353, Orladeyo®
Primary outcomes
what the primary-completion date above is the date OFArea Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Berotralstat
measured Week 2
Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6) of Berotralstat
measured Predose and up to 6 hours post dose at Week 2
Concentration at the End of the Dosing Interval (Ctrough) of Berotralstat
measured Predose at Week 2
Maximum Observed Plasma Concentration (Cmax) of Berotralstat
measured Predose and up to 6 hours post dose at Week 2
Time of Last Measurable Plasma Concentration (Tlast) of Berotralstat
measured Predose and up to 6 hours post dose at Week 2
Time to Maximum Plasma Concentration (Tmax) of Berotralstat
measured Predose and up to 6 hours post dose at Week 2
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-05 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-07-08 · 1.2 MB · SAP_001.pdf
Publications
- PMID 40716738 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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