CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 151 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.

Search/NCT00997204
NCT00997204Phase 3Completed

Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

Shire·interventional·Posted Oct 19, 2009·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating Icatibant for Hereditary Angioedema. Completed, enrolled 151 participants across 26 sites in 10 countries.

Detailed Summary

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Denmark, France, Germany, Israel, Italy, Spain, Switzerland, United Kingdom
CollaboratorsJerini AG

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2009
Enrollment StartSep 25, 2009
Primary CompletionJun 22, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.7 years ago

Interventions

Icatibantdrug

Single subcutaneous injection of icatibant, 30 mg