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Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat

NCT ID: NCT07216378

Last Updated: 2025-11-12

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

AVAILABLE

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 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.

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

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 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

Wheaton, Maryland, United States

Site Status AVAILABLE

KalVista Investigative Site

St Louis, Missouri, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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KalVista Pharmaceuticals Ltd

Role: CONTACT

Phone: 1 (857) 999-0075

Email: [email protected]

Other Identifiers

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KVD900-EAP-US-2

Identifier Type: -

Identifier Source: org_study_id