Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat

NCT06628713 | Unknown

• 1 other identifier: KVD900-EAP-US-1
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Type I or II Hereditary Angioedema (HAE) adolescent and adult post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.

Conditions

Hereditary Angioedema

Interventions

Sebetralstat DRUG

Oral Plasma Kallikrein Inhibator

Also known as: KVD900

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 12 years of age.
• Able to provide written, informed consent or assent.
• Confirmed diagnosis of HAE Type I or II.

You may not qualify if:

• Confirmed diagnosis of HAE with nC1-INH or acquired angioedema.
• Confirmed pregnancy or breast-feeding.
• Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
• Known hypersensitivity to sebetralstat or its excipients.
• Patient with a medical history or known to have severe hepatic impairment (Child Pugh C).
• Patients who require sustained use of strong cytochrome P450 3A4 inhibitors or inducers.

Sponsors & Collaborators

• KalVista Pharmaceuticals, Ltd.: lead

Study Sites (1)

KalVista Investigative Site

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

sebetralstat

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 8, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

US (1)