A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema

Trial Profile

A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2017

At a glance

  • Drugs Icatibant (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Shire
  • Most Recent Events

    • 26 Oct 2017 Results presented in a Shire media release.
    • 26 Oct 2017 According to a Shire media release, the European Commission (EC) has approved a label extension granting a new indication for icatibant injection (FIRAZYR), broadening its use to adolescents and children aged 2 years and older, with hereditary angioedema (HAE) caused by C1-esterase-inhibitor (C1-INH) deficiency. The approval for label extension was based on the results of this trial.
    • 06 Feb 2017 Planned primary completion date changed from 1 Sep 2017 to 1 Dec 2017.
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