Hereditary Angioedema (HAE)NCT07159464
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
A study testing CSL312 in people with Hereditary Angioedema (HAE), run by CSL Behring.
Trial summary
This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- CSL312
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study
This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. The continuing treatment with the study product will be administered under a Post Study Access program in accordance with the applicable laws and regulations, to be dictated by CSL Behring (Sponsor) and approved by the appropriate local/central Ethics Committees and all other competent authorities required by law, as applicable.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- CSL312
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL312Biological
Also called Garadacimab
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159464
- Sponsor's protocol ID
- CSL312_5001
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study
- ClinicalTrials.gov ID
- NCT07159464
- Acronym / sponsor ID
- CSL312_5001
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. The continuing treatment with the study product will be administered under a Post Study Access program in accordance with the applicable laws and regulations, to be dictated by CSL Behring (Sponsor) and approved by the appropriate local/central Ethics Committees and all other competent authorities required by law, as applicable.
Study design
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL312Also: GaradacimabFully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing CSL312 in people with Hereditary Angioedema (HAE), run by CSL Behring.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trial Registration Coordinator (1-610-878-4697, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.