NCT04933721Phase 3Enrolling by invitation

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2031-08Estimated

Enrollment · participants139Estimated

Source updated2025-12-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-23 · 1 field changed

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Enrolling by invitation

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Study details

Conditions studied

Hereditary Angioedema; HAE

Treatments or interventions studied

berotralstatDrugAlso known as Orladeyo

Primary outcomes · main study measures

Read the study measures

measure: Number and proportion of subjects with a treatment-related TEAE; timeFrame: 240 weeks; measure: Number and proportion of subjects who experience a serious adverse event (SAE); timeFrame: 240 weeks; measure: Number and proportion of subjects who experience a treatment-related Grade 3 or 4 TEAE; timeFrame: 240 weeks; measure: Number and proportion of subjects who experience a treatment-related Grade 3 or 4 treatment-emergent chemistry abnormality; timeFrame: 240 weeks; measure: Number and proportion of subjects who discontinue due to a TEAE; timeFrame: 240 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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