A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

NCT05509569 — Completed, 32 participants, Takeda

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Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)

Registry	NCT05509569
Status	Completed
Study type	Observational
Enrollment	32 (Actual)
Sponsor	Takeda (Industry)
Conditions	Hereditary Angioedema (HAE)
Interventions	Icatibant (Drug)
Dates	start 2022-08-24, primary completion 2026-07-17, completion 2026-07-17, first posted 2022-08-22, last updated 2026-08-07
Locations	1 site in Japan

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Icatibant		Drug: Icatibant	Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously.

Icatibant (Drug), also known as FIRAZYR Subcutaneous Injection 30mg Syringe: Icatibant, 10 to 30 mg, Subcutaneous injection

+Outcome measures

Primary outcomes

Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) [Up to 3 Months]

Secondary outcomes

Time from Onset of Seizure to Start of Treatment [Up to 3 Months]: Time from onset of seizure to the first drug administration will be assessed.
Time from First Drug Administration to Symptom Resolution [Up to 3 Months]: Time from the first drug administration to complete resolution of all symptoms of HAE will be assessed.
Duration of Seizure [Up to 3 Months]: The time from the start of the seizure to the disappearance of all symptoms will be assessed.

+Eligibility

Sex: All, ages: 2 Years to 17 Years

Inclusion Criteria:

\- All participants with HAE who are 2 to <18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.

Exclusion Criteria:

\- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.

+Locations (1)

Facility	City	Country	Status
Takeda selected site	Tokyo, Tokyo	Japan

+Investigators

Study Director, Study director, Takeda