A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

NCT ID: NCT05509569

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Icatibant

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

Icatibant

Intervention Type DRUG

Icatibant, 10 to 30 mg, Subcutaneous injection

Interventions

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Icatibant

Icatibant, 10 to 30 mg, Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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FIRAZYR Subcutaneous Injection 30mg Syringe

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda selected site

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://clinicaltrials.takeda.com/study-detail/fcb2fbc9311e4e80

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

Other Identifiers

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jRCT2031220292

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-667-4003

Identifier Type: -

Identifier Source: org_study_id

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