Clinical Trial: Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.



Original Primary Outcome: Time to Complete or Near Complete Resolution From Onset of Symptoms [ Time Frame: Time of complete or near complete improvement of symptoms as reported by the patient ]

Current Secondary Outcome: Percent Change in VAS Scores [ Time Frame: Percent Change in VAS Score from Baseline to 4 Hours ]

Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity


Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: October 13, 2011
Date Started: December 2011
Date Completion:
Last Updated: October 17, 2016
Last Verified: October 2016