NCT00997204

EASSI - Evaluation of the Safety of Self-Administration With Icatibant

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase IIIb study was multi-center and open-label with a single dose level. Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial. Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been previously treated with the marketed product Firazyr® and subjects who were naïve to icatibant treatment. All subjects were trained on the method of self-administration at their enrollment visit (Visit 1).For the training sessions, a syringe pre-filled with 3 mL placebo solution was used in place of icatibant. Comprehensive educational material and instructions including pictograms were developed for the subjects to illustrate the method of self-administration and use of the Patient Diary. The training material provided additional information on how to self-diagnose an HAE attack and how to decide on the necessity to treat.In addition, instructions were provided on what to do in case of a laryngeal attack.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	Icatibant	Single subcutaneous injection of icatibant, 30 mg

Timeline

• Start date: 2009-09-25
• Primary completion: 2011-06-22
• Completion: 2011-06-22
• First posted: 2009-10-19
• Last updated: 2021-06-11
• Results posted: 2014-07-28

Locations

26 sites across 10 countries: Argentina, Austria, Denmark, France, Germany, Israel, Italy, Spain, Switzerland, United Kingdom