Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema (ACE)
Primary Purpose
Angioedema
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
Sponsored by
About this trial
This is an interventional treatment trial for Angioedema focused on measuring acute angiotensin converting enzyme inhibitor angioedema
Eligibility Criteria
Inclusion Criteria:
- Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
- Must currently be on an ACE inhibitor
- Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
- All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
Exclusion Criteria:
- Participation in another investigational study within 30 days prior to enrollment
- Patients who improve on conventional (standard of care) therapy
- Patients previously treated with ecallantide
- Hypersensitivity to ecallantide
- Pregnancy or breast feeding
- Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
- Patients receiving C-1 inhibitor as prophylaxis
- Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
- Receiving fresh frozen plasma within 3 days prior to enrollment
Sites / Locations
- The Jewish HospitalRecruiting
- Univeristy HospitalRecruiting
- UC Physicians, Dpt of Internal Medicine, Division of ImmunologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Ecallantide in conjunction with Conventional Therapy
Conventional therapy and placebo
Historical Evaluation
Arm Description
Outcomes
Primary Outcome Measures
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
Secondary Outcome Measures
Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.
Full Information
NCT ID
NCT01036659
First Posted
December 18, 2009
Last Updated
March 8, 2012
Sponsor
Bernstein, Jonathan A., M.D.
Collaborators
Dyax Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01036659
Brief Title
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Acronym
ACE
Official Title
Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bernstein, Jonathan A., M.D.
Collaborators
Dyax Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioedema
Keywords
acute angiotensin converting enzyme inhibitor angioedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ecallantide in conjunction with Conventional Therapy
Arm Type
Active Comparator
Arm Title
Conventional therapy and placebo
Arm Type
Placebo Comparator
Arm Title
Historical Evaluation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
Intervention Description
subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.
Primary Outcome Measure Information:
Title
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
Must currently be on an ACE inhibitor
Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
Exclusion Criteria:
Participation in another investigational study within 30 days prior to enrollment
Patients who improve on conventional (standard of care) therapy
Patients previously treated with ecallantide
Hypersensitivity to ecallantide
Pregnancy or breast feeding
Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
Patients receiving C-1 inhibitor as prophylaxis
Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
Receiving fresh frozen plasma within 3 days prior to enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jillian Picard, RN
Phone
513-558-0924
Email
jillian.picard@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah J. Holmes, RN
Phone
513-558-0924
Email
sarah.holmes@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A. Bernstein, M.D.
Organizational Affiliation
UC Physicians, Division of Immunology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Moellman, MD
Organizational Affiliation
UC Physicians, Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Jewish Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian K Picard, RN, BSN
Phone
513-558-0924
Email
Jillian.picard@uc.edu
First Name & Middle Initial & Last Name & Degree
Sarah J Holmes, RN, BSN
Phone
513-558-0924
Email
Sarah.holmes@uc.edu
First Name & Middle Initial & Last Name & Degree
Joseph Moellman, MD
Facility Name
Univeristy Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian K Picard, RN, BSN
Phone
513-558-0924
Email
Jillian.picard@uc.edu
First Name & Middle Initial & Last Name & Degree
Sarah J Holmes, RN, BSN
Phone
513-558-0924
Email
Sarah.holmes@uc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan A Bernstein, MD
Facility Name
UC Physicians, Dpt of Internal Medicine, Division of Immunology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian Picard, RN
Phone
513-558-0924
Email
jillian.picard@uc.edu
First Name & Middle Initial & Last Name & Degree
Sarah J. Holmes, RN
Phone
513-558-0924
Email
sarah.holmes@uc.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
25601538
Citation
Bernstein JA, Moellman JJ, Collins SP, Hart KW, Lindsell CJ. Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. Ann Allergy Asthma Immunol. 2015 Mar;114(3):245-9. doi: 10.1016/j.anai.2014.12.007. Epub 2015 Jan 16.
Results Reference
derived
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Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
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