A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

NCT05509569 | Completed

• 2 other identifiers: TAK-667-4003jRCT2031220292
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Angioedema (HAE)

Outcome Measures

Primary Outcomes (1)

• Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)

  Up to 3 Months

Secondary Outcomes (3)

• Time from Onset of Seizure to Start of Treatment

  Up to 3 Months

• Time from First Drug Administration to Symptom Resolution

  Up to 3 Months

• Duration of Seizure

  Up to 3 Months

Study Arms (1)

Icatibant

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

Drug: Icatibant

Interventions

Icatibant DRUG

Icatibant, 10 to 30 mg, Subcutaneous injection

Also known as: FIRAZYR Subcutaneous Injection 30mg Syringe

Icatibant

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- All participants with HAE who are 2 to \<18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.

You may not qualify if:

• \- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda selected site

Tokyo, Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

icatibant; Syringes

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: August 24, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)