At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 19 enrolled
Drug / intervention
Icatibantdrug
Likely dose
Icatibant 30 mgfrom 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.
Open Label, Multicenter Study to Evaluate Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)
In Brief
A Phase 4 clinical trial evaluating Icatibant for Hereditary Angioedema. Completed, enrolled 19 participants across 5 sites.
Detailed Summary
The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesUnited States
CollaboratorsShire Human Genetic Therapies, Inc.
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionApr 2014
TodayJul 2026
First PostedOct 24, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.7 years ago
Interventions
Icatibantdrug
30 mg subcutaneous dose of Icatibant