At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
icatibantdrug
Likely dose
icatibant 0.4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating icatibant for Hereditary Angioedema (HAE). Completed, enrolled 32 participants across 26 sites in 10 countries.
Detailed Summary
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesAustralia, Austria, Canada, Colombia, Germany, Hungary, Israel, Italy, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartJan 2012
Primary CompletionMar 2018
TodayJul 2026
First PostedJul 1, 2011
Enrollment StartJan 27, 2012
Primary CompletionMar 12, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.0 years ago
Interventions
icatibantdrug
Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg