Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
Purpose
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.
Condition
- Hereditary Angioedema
Eligibility
- Eligible Ages
- Between 2 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Expanded Access
Recruiting Locations
KalVista Investigative Site
Evansville 4257227, Indiana 4921868 47715
Evansville 4257227, Indiana 4921868 47715
KalVista Investigative Site
Wheaton 4373349, Maryland 4361885 20902
Wheaton 4373349, Maryland 4361885 20902
KalVista Investigative Site
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- Status
- Available
- Sponsor
- KalVista Pharmaceuticals, Ltd.