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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History