FIRAZYR General Drug Use-Results Survey (Japan)

Overview

The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 23, 2022

Interventions

  • Drug: Firazyr
    • Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.

Arms, Groups and Cohorts

  • Firazyr
    • Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Drug Reactions
    • Time Frame: 4 Years
    • Number of participants with adverse drug reactions will be assessed.
  • Time to Treatment for Attack
    • Time Frame: 3 Months
    • Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack will be assessed.
  • Time to First Symptom Relief
    • Time Frame: 3 Months
    • Time to first symptom relief will be assessed.
  • Time to Complete Resolution of Attack
    • Time Frame: 3 Months
    • Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack will be assessed.
  • Total Duration of Attack
    • Time Frame: 3 Months
    • Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack will be assessed.

Participating in This Clinical Trial

Inclusion Criteria

  • Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.

Exclusion Criteria

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Shire
  • Overall Contact(s)
    • Shire Contact, +1 866 842 5335, ClinicalTransparency@shire.com

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