The sebetralstat Early Access Program (EAP) provides early access to the investigationalmedicinal product (IMP) sebetralstat to eligible and approved Type I or II HereditaryAngioedema (HAE) adolescent and adult post-trial and naïve patients for the on-demandtreatment of angioedema attacks where the treating Physician determines they mightbenefit from this treatment.
Not Provided
Drug: Sebetralstat
Oral Plasma Kallikrein Inhibator
Other Name: KVD900
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.
KalVista Investigative Site
Scottsdale, Arizona, United States
KalVista Pharmaceuticals Ltd
1 (857) 999-0075
expandedaccess@kalvista.com
Not Provided