Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)

Inclusion criteria

• 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
• Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
• Patients must be able to swallow trial tablets whole
• Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire
• Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
• Patient provides informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required

Exclusion criteria

• 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
• Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial
• History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
• Known hypersensitivity to sebetralstat or to any of the excipients
• Participation in any gene therapy treatment or trial for HAE
• Any pregnant or breastfeeding patient