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Promising HAE prevention drug now available for kids in Follow-Up study

NCT ID NCT07159464

Disease control Sponsor: CSL Behring 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study offers children aged 2 to 11 with hereditary angioedema (HAE) continued access to garadacimab, a lab-made antibody that helps prevent sudden, painful swelling attacks. Participants must have completed a prior study and shown good response with few or no attacks. The goal is to keep providing this preventive treatment while monitoring long-term safety and benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Garadacimab (a lab-made antibody injected under the skin)
What this could lead to
If successful, this could offer a safe, ongoing prevention option for children with hereditary angioedema, reducing the frequency of painful swelling attacks.
What could go wrong
This is an open-label extension study with no placebo group, so results may be less reliable. Long-term safety in young children is still being monitored.

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

Up 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: * Completion of treatment period in study CSL312\_3003 (NCT05819775) * The participant responded to CSL312 treatment with no or very limited number of HAE attacks during the CSL312\_3003 study * The participant experienced no clinically significant adverse effects associated with CSL312 treatment * In the opinion of the treating physician, the participant continues to receive benefit from CSL312 * There is no other suitable alternative prophylactic treatment available at the time of consenting into the Post Study Access program Exclusion Criteria: * In the opinion of the treating physician, participant may not be compliant with the Protocol requirements * Participant is 12 years or older at the time of consent * In the opinion of the treating physician, other study medication of prophylaxis treatment of HAE may benefit the participant more than continuing treatment with CSL312 * Participant who is pregnant, breastfeeding, or not willing to cease breastfeeding

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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 (HAE)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.