DRUG
Icatibant
Icatibant, 10 to 30 mg, Subcutaneous injection
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
Status
Completed
Phase
Not applicable
Enrollment
32
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 22, 2022
Study start
Aug 24, 2022
Primary completion
May 29, 2026
Study completion
May 29, 2026
Results posted
Not reported
Registry updated
Jul 8, 2026
Outcomes
What the study measures.
Primary outcomes
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Time frame · Up to 3 Months
Secondary outcomes
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.
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.
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.
Eligibility
Who can take part.
- Minimum age
- 2 Years
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Takeda selected site
Tokyo, Tokyo, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Icatibant.
NCT IDStudyPhase / statusEnrollmentUpdated
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
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Recruiting
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2026-04
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
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1,500
2026-03
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
Takeda · Hereditary Angioedema (HAE)
Not applicable
Completed
115
2026-01
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
KalVista Pharmaceuticals, Ltd. · Hereditary Angioedema
Not applicable
Completed
88
2026-01
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
Nang Kuang Pharmaceutical Co., Ltd. · Bradykinin-mediated Angioedema · Hereditary Angioedema (HAE)
Phase 4
Completed
5
2025-12
Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2
Vanderbilt University Medical Center · Heart Failure
Phase 4
Completed
46
2025-08
FIRAZYR General Drug Use-Results Survey (Japan)
Shire · Hereditary Angioedema (HAE)
Not applicable
Completed
179
2025-02
A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People
Takeda · Hereditary Angioedema (HAE)
Not applicable
Completed
19
2025-02
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Put the record in context.
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