A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

Hereditary Angioedema (HAE) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509569
• Other study ID #: TAK-667-4003
• Secondary ID: jRCT2031220292
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Drug:
• Icatibant
Icatibant, 10 to 30 mg, Subcutaneous injection

Locations

Country	Name	City	State
Japan	Takeda selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)		Up to 3 Months
Secondary	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
Secondary	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
Secondary	Duration of Seizure	The time from the start of the seizure to the disappearance of all symptoms will be assessed.	Up to 3 Months

External Links

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