Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
NCT ID: NCT01343823
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2011-06-01
2012-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ecallantide 10mg
Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.
ecallantide 10 mg
Administered as one 3 mL SC injection containing 10 mg ecallantide.
placebo match for 10 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
placebo
Administered as two SC 3 mL injections
placebo
Administered as two SC 3 mL injections
ecallantide 60mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
ecallantide 60 mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
ecallantide 30mg
Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.
ecallantide 30 mg
Administered as one 3 mL SC injection containing 30 mg ecallantide
placebo match for 30 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
Interventions
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ecallantide 60 mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
ecallantide 30 mg
Administered as one 3 mL SC injection containing 30 mg ecallantide
ecallantide 10 mg
Administered as one 3 mL SC injection containing 10 mg ecallantide.
placebo
Administered as two SC 3 mL injections
placebo match for 30 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
placebo match for 10 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Er Med, Llc
Montgomery, Alabama, United States
Arrowhead Regional Medical Center
Colton, California, United States
University of California Los Angeles School of Medicine
Los Angeles, California, United States
University of California San Diego Mecial Center
San Diego, California, United States
Christiana Hospital, Department of Emergency Medicine
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Georgia Health Sciences University
Augusta, Georgia, United States
DeKalb Medical
Decatur, Georgia, United States
University Consultants in Allergy and Immunology
Chicago, Illinois, United States
Mercy Hospital and Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Beaumont Hospital, Troy
Troy, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nevada Acess to Research and Education Study
Las Vegas, Nevada, United States
Kings County Hospital Center
Brooklyn, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The MetroHealth System
Cleveland, Ohio, United States
University Hospital East
Columbus, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University Medical Center Brackenridge
Austin, Texas, United States
St Joseph Regional Health Center
Bryan, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Emergency Medicine Residency Program
Fort Worth, Texas, United States
301 University Blvd.
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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References
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Lewis LM, Graffeo C, Crosley P, Klausner HA, Clark CL, Frank A, Miner J, Iarrobino R, Chyung Y. Ecallantide for the acute treatment of angiotensin-converting enzyme inhibitor-induced angioedema: a multicenter, randomized, controlled trial. Ann Emerg Med. 2015 Feb;65(2):204-13. doi: 10.1016/j.annemergmed.2014.07.014. Epub 2014 Aug 30.
Other Identifiers
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DX-88/27
Identifier Type: -
Identifier Source: org_study_id
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