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)

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.

Study Overview

• Status: Completed
• Conditions: Hereditary Angioedema (HAE)
• Intervention / Treatment: Drug: Icatibant

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Tokyo, Tokyo, Japan
      • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population of this survey are all participants who meet the inclusion/exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Icatibant; Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously.	Drug: Icatibant; Icatibant, 10 to 30 mg, Subcutaneous injection; Other Names: FIRAZYR Subcutaneous Injection 30mg Syringe

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immunologic Deficiency Syndromes; Skin Diseases; Urticaria; Skin Diseases, Vascular; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Angioedema; Angioedemas, Hereditary; Equipment and Supplies; icatibant; Syringes
• Other Study ID Numbers: TAK-667-4003; jRCT2031220292 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No