Loading clinical trials...

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

AVAILABLE

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

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

NCT07216378•KalVista Pharmaceuticals, Ltd.

View on ClinicalTrials.gov

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) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (3)

KalVista Investigative Site

Evansville, Indiana, United States

KalVista Investigative Site

Wheaton, Maryland, United States

KalVista Investigative Site

St Louis, Missouri, United States

Key Dates

Last Updated

February 4, 2026

Conditions

Hereditary Angioedema

Interventions

Sebetralstat

DRUG

Contacts

KalVista Pharmaceuticals Ltd

CONTACT

1 (857) 999-0075 expandedaccess@kalvista.com

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

View study

RECRUITINGPHASE3

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

NCT06960213

Hereditary AngioedemaHAE+2 more

View study

RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

A Study of Navenibart in Participants With Hereditary Angioedema

Institutional Registry of Rare Diseases

HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)