A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05509569

Enrollment

Registered

2022-08-22

Start date

2022-08-24

Completion date

2026-07-17

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema (HAE)

Brief 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.

Interventions

DRUGIcatibant

Icatibant, 10 to 30 mg, Subcutaneous injection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Japan

Contacts

STUDY_DIRECTORStudy Director

Takeda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026