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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05509569
Other study ID # TAK-667-4003
Secondary ID jRCT2031220292
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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