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New hope for kids with rare swelling disorder: early access drug offered

NCT ID NCT07216378

Disease control Sponsor: KalVista Pharmaceuticals, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This program provides early access to an investigational drug called sebetralstat for children aged 2 to 11 with hereditary angioedema (HAE), a condition causing sudden, painful swelling. The drug is taken at the start of an attack to reduce symptoms. It is available to children who have previously been in a sebetralstat study or are new to the drug, if their doctor believes it may help.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • KalVista Investigative Site

    AVAILABLE

    San Diego, California, 92123, United States

  • KalVista Investigative Site

    AVAILABLE

    Evansville, Indiana, 47715, United States

  • KalVista Investigative Site

    AVAILABLE

    Wheaton, Maryland, 20902, United States

  • KalVista Investigative Site

    AVAILABLE

    St Louis, Missouri, 63110, United States

  • KalVista Investigative Site

    AVAILABLE

    Knoxville, Tennessee, 37909, United States

  • KalVista Investigative Site

    AVAILABLE

    San Antonio, Texas, 78229, United States

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