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A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
Sponsor: Takeda
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
Conditions
Interventions
Icatibant
Icatibant, 10 to 30 mg, Subcutaneous injection
Locations (1)
Takeda selected site
Tokyo, Tokyo, Japan