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Completed

NCT Number: NCT05509569

A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

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.

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Key information

Conditions

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

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Icatibant

Drug

Icatibant, 10 to 30 mg, Subcutaneous injection

Other names: FIRAZYR Subcutaneous Injection 30mg Syringe

Primary outcomes

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

    Time frame: Up to 3 Months

Secondary outcomes

  1. Time from Onset of Seizure to Start of Treatment

    Time frame: Up to 3 Months

    Time from onset of seizure to the first drug administration will be assessed.

  2. Time from First Drug Administration to Symptom Resolution

    Time frame: Up to 3 Months

    Time from the first drug administration to complete resolution of all symptoms of HAE will be assessed.

  3. Duration of Seizure

    Time frame: Up to 3 Months

    The time from the start of the seizure to the disappearance of all symptoms will be assessed.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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