A Phase 4, Open-Label Trial to Evaluate the Safety and Effectiveness of Sebetralstat When Used as Preprocedural Short-term Prophylaxis in Patients With Hereditary Angioedema
KalVista Pharmaceuticals, Ltd.
Summary
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).
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients ≥12 years of age at time of Screening 2. Confirmed diagnosis of HAE Type I or II based on patient report 3. Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening 4. Patient has access to a commercial available on-demand treatment for HAE 5. Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception) 6. Patients must be able to swallow trial tablets whole 7. Pa…
Interventions
- DrugKVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Location
- KalVista Investigative SiteColorado Springs, Colorado