Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
- Conditions
- Hereditary Angioedema
- Registration Number
- NCT06628713
- Lead Sponsor
- KalVista Pharmaceuticals, Ltd.
- Brief Summary
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Type I or II Hereditary Angioedema (HAE) adolescent and adult post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- At least 12 years of age.
- Able to provide written, informed consent or assent.
- Confirmed diagnosis of HAE Type I or II.
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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.
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method