Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) with HAE Type I or II

Eligibility Criteria

• 1. Male or female patients 2 to 11 years of age.
• 2. Confirmed diagnosis of HAE Type I or II.
• 3. Patient has had at least 1 documented HAE attack in the last year prior to screening.
• 4. Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
• 5. Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
• 6. Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).
• 1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria.
• 2. 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.
• 3. Patient weighs \<9.5 kg.
• 4. Use of angiotensin-converting enzyme inhibitors after the Screening Visit.
• 5. 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.
• 6. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
• 7. 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.
• 8. Known hypersensitivity to sebetralstat or to any of the excipients.
• 9. Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.