Hereditary Angioedema
Conditions
Brief summary
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.
Interventions
DRUGSebetralstat
Oral Plasma Kallikrein Inhibator
Sponsors
KalVista Pharmaceuticals, Ltd.
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
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.
Countries
United States
Contacts
CONTACTKalVista Pharmaceuticals Ltd
Outcome results
None listed