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

NCT ID: NCT06628713

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Hereditary Angioedema

Interventions

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Sebetralstat

Oral Plasma Kallikrein Inhibator

Intervention Type DRUG

Other Intervention Names

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KVD900

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KalVista Pharmaceuticals, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KalVista Investigative Site

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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KVD900-EAP-US-1

Identifier Type: -

Identifier Source: org_study_id

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