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
Price :
$35
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At a glance
- Drugs Icatibant (Primary)
- Indications Hereditary angioedema
- Focus Adverse reactions; Pharmacokinetics; Registrational
- Sponsors Shire
- 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.