Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
On Demand Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With Hereditary Angioedema (HAE) With Sebetralstat
1 other identifier
expanded_access
N/A
1 country
3
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.
Trial Health
Trial Health Score
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3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
October 14, 2025
CompletedFebruary 4, 2026
February 1, 2026
September 12, 2025
February 3, 2026
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
KalVista Investigative Site
Evansville, Indiana, 47715, United States
KalVista Investigative Site
Wheaton, Maryland, 20902, United States
KalVista Investigative Site
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
October 14, 2025
Last Updated
February 4, 2026
Record last verified: 2026-02