FindTrial
Sign In

Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat

On Demand Treatment of Angioedema Attacks in Adolescent and Adult Post-Trial and Naive Patients 12 Years and Older With Hereditary Angioedema (HAE) Type I or II With Sebetralstat

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT06628713
Enrollment
Unknown
Registered
2024-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

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.

Interventions

DRUGSebetralstat

Oral Plasma Kallikrein Inhibator

Sponsors

KalVista Pharmaceuticals, Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026