Hereditary Angioedema (HAE)NCT05509569
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
An observational study of Hereditary Angioedema (HAE), run by Takeda at 1 site in Japan.
Trial summary
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- Icatibant
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 24 Aug 2022to 17 Jul 2026
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- All participants with HAE who are 2 to <18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.
Who cannot join
- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE.
During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- Icatibant
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcatibantDrug
Also called FIRAZYR Subcutaneous Injection 30mg Syringe
Icatibant, 10 to 30 mg, Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Icatibant | Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously. Receives: Drug: Icatibant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Measured: Up to 3 Months
Secondary outcomes (3)
Time from Onset of Seizure to Start of Treatment
Time from onset of seizure to the first drug administration will be assessed.
Measured: Up to 3 Months
Time from First Drug Administration to Symptom Resolution
Time from the first drug administration to complete resolution of all symptoms of HAE will be assessed.
Measured: Up to 3 Months
Duration of Seizure
The time from the start of the seizure to the disappearance of all symptoms will be assessed.
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start24 Aug 2022
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
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 TakedaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509569
- Sponsor's protocol ID
- TAK-667-4003
- Other IDs
- jRCT2031220292
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)
- ClinicalTrials.gov ID
- NCT05509569
- Acronym / sponsor ID
- TAK-667-4003
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 22 Aug 2022 (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 study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE.
During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icatibant | – | Drug: IcatibantParticipants will be recieved Icatibant 10 to 30 mg injection subcutaneously. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population of this survey are all participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- All participants with HAE who are 2 to <18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.
Key exclusion criteria (1 listed)
- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.
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 |
|---|---|---|
| IcatibantAlso: FIRAZYR Subcutaneous Injection 30mg SyringeIcatibant, 10 to 30 mg, Subcutaneous injection | Drug | Icatibant |
Primary outcome
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 3 Months
3 secondary outcomes
Time from Onset of Seizure to Start of Treatment
Time frame: Up to 3 Months
Time from First Drug Administration to Symptom Resolution
Time frame: Up to 3 Months
Duration of Seizure
Time frame: Up to 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema (HAE), run by Takeda at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) (time frame: Up to 3 Months). It is what the study was designed to measure, not a finding.
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 7 Aug 2026.