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

Available (expanded access)

Conditions studied: Hereditary Angioedema

In brief

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.

Key facts

Study ID

NCT07216378

Run by

KalVista Pharmaceuticals, Ltd.

Last updated by the study team

2026-07-23

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• KalVista Investigative Site — San Diego, California, United States
• KalVista Investigative Site — Evansville, Indiana, United States
• KalVista Investigative Site — Wheaton, Maryland, United States
• KalVista Investigative Site — St Louis, Missouri, United States
• KalVista Investigative Site — Knoxville, Tennessee, United States
• KalVista Investigative Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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