Overview
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Eligibility
Inclusion Criteria:
- Male or female patients 2 to 11 years of age.
- Confirmed diagnosis of HAE Type I or II.
- For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
- 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.
- Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
- Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).
Exclusion Criteria:
- 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.
- 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.
- Patient weighs <9.5 kg.
- Use of angiotensin-converting enzyme inhibitors after 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 require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
- 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.
- Known hypersensitivity to sebetralstat or to any of the excipients.
- Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.
