NCT05509569

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
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	Icatibant	Icatibant, 10 to 30 mg, Subcutaneous injection

Timeline

• Start date: 2022-08-24
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-08-22
• Last updated: 2025-11-17

Locations

1 site across 1 country: Japan