NCT01457430

Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	Icatibant	30 mg subcutaneous dose of Icatibant

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-10-24
• Last updated: 2016-10-18
• Results posted: 2016-10-18

Locations

5 sites across 1 country: United States