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 ]

Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Evaluate safety for the ecallantide-treated and placebo-treated patients.


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