Safety and Effectiveness of Sebetralstat for Short-Term Prevention Before Procedures in People With Hereditary Angioedema

Sponsor
KalVista Pharmaceuticals, Ltd.
Study ID
NCT07654829
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KVD900 600 mg — DRUG
    KVD900 Tablet 600 mg (2 x 300 mg)

Study Details

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).

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Nov 29, 2027
Completion
Dec 6, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KVD900 600 mg

Primary Outcome Measure

The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized. [ Time Frame: 24 hours following the start of the procedure ]

Central Contacts

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