A Survey of Icatibant in Pediatric Participants With Here... | NCT05509569

Studies
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

NCT05509569

Sponsor

Takeda

Status

Completed

Last Update Posted

Jul 8, 2026Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Hereditary Angioedema (HAE)

Interventions

Icatibant

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
jRCT2031220292	Registry Identifier	jRCT

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2022Actual

Primary Completion Date

May 29, 2026Actual

Completion Date

May 29, 2026Actual

First Submitted Date

Aug 19, 2022

First Submission Date that Met QC Criteria

Aug 19, 2022

First Posted Date

Aug 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Icatibant		Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously.	Drug: Icatibant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icatibant	Drug	Icatibant, 10 to 30 mg, Subcutaneous injection	Icatibant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)		Up to 3 Months

Secondary Outcomes

Measure	Description	Time Frame
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
Time from First Drug Administration to Symptom Resolution

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Takeda selected site		Tokyo	Tokyo		Japan

References Module

Citations

Not provided

Label	URL
To obtain more information on the study, click here/on this link	View source
Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.	View source

ID	Term
D000799	Angioedema
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000081208	Hereditary Complement Deficiency Diseases

ID	Term
C065679	icatibant
D013594	Syringes