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COMPLETED
NCT05509569

A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

Sponsor: Takeda

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

32

Start Date

2022-08-24

Completion Date

2026-05-29

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Icatibant

Icatibant, 10 to 30 mg, Subcutaneous injection

Locations (1)

Takeda selected site

Tokyo, Tokyo, Japan