NCT06467084

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

Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: KalVista Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	KVD900 150 mg	KVD900 Tablet 150 mg (2 x 75 mg)
DRUG	KVD900 300 mg	KVD900 Tablet 300 mg (1 x 300 mg)
DRUG	KVD900 600 mg	KVD900 Tablet 600 mg (2 x 300 mg)

Timeline

• Start date: 2024-06-24
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2024-06-20
• Last updated: 2026-01-23

Locations

24 sites across 7 countries: United States, Canada, France, Germany, Israel, Italy, Japan

Regulatory

• FDA-regulated drug study