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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

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

Most Recent Events

  • 12 Dec 2020 This trial has been Discontinued in Hungary, according to European Clinical Trials Database record.
  • 22 Oct 2020 Population pharmacokinetics and exposure response analyses was performed to guide dosing of Icatibant in pediatric patients using data from 6 trials (HGT-FIR-061,-065, -086, JE049-1102,-1103 and JE049-1102) ; results published in the Journal of Clinical Pharmacology
  • 29 Mar 2019 Argentina, Canada were planned locations as per European Clinical Trials Database record.

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