At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 98 enrolled
Drug / intervention
Icatibant +1 moredrug
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.
A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)
In Brief
A Phase 3 clinical trial evaluating Icatibant and Placebo for Hereditary Angioedema. Completed, enrolled 98 participants across 64 sites in 9 countries.
Detailed Summary
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesAustralia, Canada, Hungary, Israel, Romania, Russia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJul 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedJun 3, 2009
Enrollment StartJul 16, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.1 years ago
Interventions
Icatibantdrug
Single subcutaneous injection of icatibant, 30 mg
Placebodrug
Single subcutaneous injection of matching placebo