This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
Male or female patients ≥12 years of age at time of Screening
Confirmed diagnosis of HAE Type I or II based on patient report
Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
Patient has access to a commercial available on-demand treatment for HAE
A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator
Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit
Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
Single group
KVD900 600 mg
DrugKVD900 Tablet 600 mg (2 x 300 mg)
The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized.
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