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

KalVista Pharmaceuticals

Status

Conditions: Hereditary Angioedema

Treatments: Drug: Sebetralstat

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06628713

KVD900-EAP-US-1

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 12 years of age.
• Able to provide written, informed consent or assent.
• Confirmed diagnosis of HAE Type I or II.

Exclusion criteria

• 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.