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

KalVista Pharmaceuticals

Status

Conditions: Hereditary Angioedema

Treatments: Drug: Sebetralstat

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07216378

KVD900-EAP-US-2

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 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.

Sex: All

Ages: 2 to 11 years old

Volunteers: No 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.