A Survey of Icatibant in Pediatric Participants with Hereditary Angioedema

Active, not recruiting

• Conditions: Hereditary Angioedema (HAE)
• Interventions: Drug: Icatibant

• Registration Number: NCT05509569
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-08-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Icatibant	Icatibant	Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Takeda selected site; 🇯🇴 Tokyo, Jordan