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

• Conditions: Hereditary Angioedema

• Registration Number: NCT07216378
• Lead Sponsor: KalVista Pharmaceuticals, Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-10-08
• Study First Posted: 2025-10-14
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-10
• Last Update Posted: 2025-11-12

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

KalVista Investigative Site; 🇺🇸 St Louis, Missouri, United States