Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
- Conditions
- ACE Inhibitor Induced Angioedema
- Interventions
- Drug: placeboDrug: placebo match for 30 mg ecallantide armDrug: placebo match for 10 mg ecallantide arm
- Registration Number
- NCT01343823
- Lead Sponsor
- Shire
- Brief Summary
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- Males and females 18 years of age or older
- Must currently be on ACE inhibitor therapy and have received a dose within 36 hours
- Presenting with ACEIA of the head/neck region within 12 hours after onset
- All females must have a negative urine pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test.
- Hypersensitivity to ecallantide
- Pregnancy or breast feeding
- Patients who have had angioedema and were not concurrently on an ACE inhibitor
- Patients exhibiting urticaria
- Patients who are intubated or who have a tracheostomy related to the current episode of angioedema
- Opinion of the investigator that the patient would not be a good candidate
- Participation in another investigational study within 30 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ecallantide 30mg placebo match for 30 mg ecallantide arm Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo. ecallantide 30mg ecallantide 30 mg Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo. ecallantide 10mg ecallantide 10 mg Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. ecallantide 10mg placebo match for 10 mg ecallantide arm Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. placebo placebo Administered as two SC 3 mL injections ecallantide 60mg ecallantide 60 mg Administered as two 3 mL SC injections, each containing 30 mg ecallantide
- Primary Outcome Measures
Name Time Method Safety and Efficacy of Ecallantide 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
- Secondary Outcome Measures
Name Time Method Time to Symptom Resolution Based on the Visual Analog Scale (VAS) 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".
Related Research Topics
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Trial Locations
- Locations (39)
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University Hospital East
🇺🇸Columbus, Ohio, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Beaumont Hospital, Royal Oak
🇺🇸Royal Oak, Michigan, United States
Kings County Hospital Center
🇺🇸Brooklyn, New York, United States
Beaumont Hospital, Troy
🇺🇸Troy, Michigan, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Emergency Medicine Residency Program
🇺🇸Fort Worth, Texas, United States
301 University Blvd.
🇺🇸Galveston, Texas, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of California San Diego Mecial Center
🇺🇸San Diego, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Nevada Acess to Research and Education Study
🇺🇸Las Vegas, Nevada, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Er Med, Llc
🇺🇸Montgomery, Alabama, United States
University of California Los Angeles School of Medicine
🇺🇸Los Angeles, California, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Christiana Hospital, Department of Emergency Medicine
🇺🇸Newark, Delaware, United States
University Consultants in Allergy and Immunology
🇺🇸Chicago, Illinois, United States
DeKalb Medical
🇺🇸Decatur, Georgia, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St Joseph Regional Health Center
🇺🇸Bryan, Texas, United States
University Medical Center Brackenridge
🇺🇸Austin, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States