Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat

Status:

AVAILABLE

Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat

Lead Sponsor:

KalVista Pharmaceuticals, Ltd.

Conditions:

Hereditary Angioedema

Eligibility:

All Genders

2-11 years

Brief Summary

The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11)...

Eligibility Criteria

Inclusion

Male or female patients 2 to 11 years of age.
Parent or LAR provides signed informed consent and patient provides assent (when applicable).
Confirmed diagnosis of HAE.

Exclusion

Confirmed diagnosis of HAE with nC1-INH or acquired angioedema
Patient weighs \<9.5 kg
Patient participated in the KVD900-303 trial and withdrew prior to trial completion per the protocol or trial closure
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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT07216378

Last Update

November 12 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

KalVista Investigative Site

Wheaton, Maryland, United States, 20902