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A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

Sponsor
Takeda (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05509569
Collaborator
(none)
10
Enrollment
36.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)
Anticipated Study Start Date :
Aug 24, 2022
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Icatibant

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

Drug: Icatibant
Icatibant, 10 to 30 mg, Subcutaneous injection
Other Names:
  • FIRAZYR Subcutaneous Injection 30mg Syringe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) [Up to 3 Months]

    Secondary Outcome Measures

    1. Time from Onset of Seizure to Start of Treatment [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 [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 [Up to 3 Months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05509569
    Other Study ID Numbers:
    • TAK-667-4003
    First Posted:
    Aug 22, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Angioedema
    Angioedemas, Hereditary
    Icatibant

    Study Results

    No Results Posted as of Aug 22, 2022