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

APPROVED_FOR_MARKETING

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 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.

Key facts

Study ID

NCT06628713

Run by

KalVista Pharmaceuticals, Ltd.

Last updated by the study team

2025-08-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• KalVista Investigative Site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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