The sebetralstat Early Access Program (EAP) provides early access to the investigationalmedicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE)pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment ofangioedema attacks where the treating Physician determines they might benefit from thistreatment.
Not Provided
Drug: Sebetralstat
Oral Plasma Kallikrein Inhibator
Other Name: KVD900
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.
KalVista Investigative Site
Evansville, Indiana, United States
KalVista Investigative Site
Wheaton, Maryland, United States
KalVista Investigative Site
St Louis, Missouri, United States
KalVista Pharmaceuticals Ltd
1 (857) 999-0075
expandedaccess@kalvista.com
Not Provided