Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
NCT07654829 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-07-16
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).
Conditions
Interventions
- DRUG
-
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Sponsors & Collaborators
-
KalVista Pharmaceuticals, Ltd.
lead INDUSTRY
Principal Investigators
-
Study Director · KalVista Pharmaceuticals, Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-11-29
- Completion
- 2027-12-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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