Clinical trial NCT01343823: Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
Official title: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: ACE Inhibitor Induced Angioedema
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety and Efficacy of Ecallantide
timeFrame: 6 hours
Secondary outcomes:
measure: Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Er Med, Llc
state: Alabama
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles School of Medicine
state: California
city: San Diego
country: United States
facility: University of California San Diego Mecial Center
state: California
city: Newark
country: United States
facility: Christiana Hospital, Department of Emergency Medicine
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical
state: Georgia
city: Chicago
country: United States
facility: University Consultants in Allergy and Immunology
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital, Troy
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Acess to Research and Education Study
state: Nevada
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Columbus
country: United States
facility: University Hospital East
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: University Medical Center Brackenridge
state: Texas
city: Bryan
country: United States
facility: St Joseph Regional Health Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Emergency Medicine Residency Program
state: Texas
city: Galveston
country: United States
facility: 301 University Blvd.
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.