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Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

Primary Purpose

ACE Inhibitor Induced Angioedema

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ecallantide 60 mg
ecallantide 30 mg
ecallantide 10 mg
placebo
placebo match for 30 mg ecallantide arm
placebo match for 10 mg ecallantide arm
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACE Inhibitor Induced Angioedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Er Med, Llc
  • Arrowhead Regional Medical Center
  • University of California Los Angeles School of Medicine
  • University of California San Diego Mecial Center
  • Christiana Hospital, Department of Emergency Medicine
  • Washington Hospital Center
  • Tampa General Hospital
  • Georgia Health Sciences University
  • DeKalb Medical
  • University Consultants in Allergy and Immunology
  • Mercy Hospital and Medical Center
  • University of Kansas Medical Center
  • Ochsner Clinic Foundation
  • Henry Ford Hospital
  • Beaumont Hospital, Royal Oak
  • Beaumont Hospital, Troy
  • Hennepin County Medical Center
  • Washington University School of Medicine
  • Nevada Acess to Research and Education Study
  • Kings County Hospital Center
  • Winthrop University Hospital
  • Staten Island University Hospital
  • East Carolina University
  • Wake Forest Baptist Health
  • The MetroHealth System
  • University Hospital East
  • The Ohio State University Medical Center
  • Thomas Jefferson University
  • Albert Einstein Medical Center
  • Allegheny General Hospital
  • Medical University of South Carolina
  • University Medical Center Brackenridge
  • St Joseph Regional Health Center
  • UT Southwestern Medical Center at Dallas
  • Emergency Medicine Residency Program
  • 301 University Blvd.
  • Baylor College of Medicine
  • University of Virginia Health System
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

ecallantide 10mg

placebo

ecallantide 60mg

ecallantide 30mg

Arm Description

Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.

Administered as two SC 3 mL injections

Administered as two 3 mL SC injections, each containing 30 mg ecallantide

Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.

Outcomes

Primary Outcome Measures

Safety and Efficacy of Ecallantide
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

Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
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".

Full Information

First Posted
April 27, 2011
Last Updated
May 18, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01343823
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.
Study Start Date
June 1, 2011 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACE Inhibitor Induced Angioedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ecallantide 10mg
Arm Type
Active Comparator
Arm Description
Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Administered as two SC 3 mL injections
Arm Title
ecallantide 60mg
Arm Type
Active Comparator
Arm Description
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
Arm Title
ecallantide 30mg
Arm Type
Active Comparator
Arm Description
Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.
Intervention Type
Drug
Intervention Name(s)
ecallantide 60 mg
Intervention Description
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
Intervention Type
Drug
Intervention Name(s)
ecallantide 30 mg
Intervention Description
Administered as one 3 mL SC injection containing 30 mg ecallantide
Intervention Type
Drug
Intervention Name(s)
ecallantide 10 mg
Intervention Description
Administered as one 3 mL SC injection containing 10 mg ecallantide.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered as two SC 3 mL injections
Intervention Type
Drug
Intervention Name(s)
placebo match for 30 mg ecallantide arm
Intervention Description
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
Intervention Type
Drug
Intervention Name(s)
placebo match for 10 mg ecallantide arm
Intervention Description
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
Primary Outcome Measure Information:
Title
Safety and Efficacy of Ecallantide
Description
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
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
Description
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".
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Er Med, Llc
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Arrowhead Regional Medical Center
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
University of California Los Angeles School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Diego Mecial Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Christiana Hospital, Department of Emergency Medicine
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DeKalb Medical
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University Consultants in Allergy and Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Beaumont Hospital, Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Acess to Research and Education Study
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
University Hospital East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University Medical Center Brackenridge
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
St Joseph Regional Health Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Emergency Medicine Residency Program
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
301 University Blvd.
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25182544
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.
Results Reference
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Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

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