Clinical Trial: Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Brief Summary: A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Safety and Efficacy of Ecallantide [ Time Frame: 6 hours ]
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy.
Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER.
A responder was defined as a patient meeting all six discharge eligibility criteria as below:
- Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale
- Stable vital signs (within an acceptable range)
- Absence of stridor
- Absence of dyspnea or use of accessory muscles during respiration
- Absence of drooling
- Able to drink without difficulty
Original Primary Outcome: Safety and Efficacy of Ecallantide [ Time Frame: 1 week ]
Current Secondary Outcome: Time to Symptom Resolution Based on the Visual Analog Scale (VAS) [ Time Frame: 6 hours ]
Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups.
The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from "totally resolved" to "very severe".
Original Secondary Outcome:
- assess the efficacy of ecallantide [ Time Frame: 1 week ]Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. Compare the proportion of patients in the ecallantide-treated and placebo-treated groups meeting primary endpoint criteria without return of symptoms at 24 hours post dose.
- compare need for intervention or hospitalization [ Time Frame: 1 week ]Compare the ecallantide-treated and placebo-treated groups for the need for intervention to support airway; for the use of additional medication as rescue therapy; for rates of admission to ICU or step down unit
Information By: Shire
Dates:
Date Received: April 27, 2011
Date Started: June 2011
Date Completion:
Last Updated: June 28, 2016
Last Verified: June 2016