ACE Inhibitor Induced AngioedemaPhase 2NCT01343823
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
A Phase 2 study testing ecallantide 60 mg, ecallantide 30 mg and ecallantide 10 mg in people with ACE Inhibitor Induced Angioedema, run by Shire at 39 sites in United States.
Trial summary
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACE Inhibitor Induced Angioedema
- What is being tested?
- ecallantide 60 mg, ecallantide 30 mg and ecallantide 10 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 39 sitesUnited States
- Study dates
- 1 Jun 2011to 1 Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Georgia Health Sciences University
Augusta, Georgia, 30912
University Medical Center Brackenridge
Austin, Texas, 78701
Kings County Hospital Center
Brooklyn, New York, 11203
St Joseph Regional Health Center
Bryan, Texas, 77802
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22908
University Consultants in Allergy and Immunology
Chicago, Illinois, 60612
Mercy Hospital and Medical Center
Chicago, Illinois, 60616
The MetroHealth System
Cleveland, Ohio, 44109
Arrowhead Regional Medical Center
Colton, California, 92324
University Hospital East
Columbus, Ohio, 43205
The Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
DeKalb Medical
Decatur, Georgia, 30033
Henry Ford Hospital
Detroit, Michigan, 48202
Emergency Medicine Residency Program
Fort Worth, Texas, 76104
301 University Blvd.
Galveston, Texas, 77555
East Carolina University
Greenville, North Carolina, 27834
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Nevada Acess to Research and Education Study
Las Vegas, Nevada, 89106
University of California Los Angeles School of Medicine
Los Angeles, California, 90095
Winthrop University Hospital
Mineola, New York, 11501
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Er Med, Llc
Montgomery, Alabama, 36106
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Christiana Hospital, Department of Emergency Medicine
Newark, Delaware, 19718
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
University of California San Diego Mecial Center
San Diego, California, 92103
Washington University School of Medicine
St Louis, Missouri, 63110
Staten Island University Hospital
Staten Island, New York, 10305
Tampa General Hospital
Tampa, Florida, 33606
Beaumont Hospital, Troy
Troy, Michigan, 48085
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
- Conditions
- ACE Inhibitor Induced Angioedema
- Being tested
- ecallantide 60 mg, ecallantide 30 mg, ecallantide 10 mg, placebo, placebo match for 30 mg ecallantide arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecallantide 60 mgDrug
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
ecallantide 30 mgDrug
Administered as one 3 mL SC injection containing 30 mg ecallantide
ecallantide 10 mgDrug
Administered as one 3 mL SC injection containing 10 mg ecallantide.
placeboDrug
Administered as two SC 3 mL injections
placebo match for 30 mg ecallantide armDrug
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
placebo match for 10 mg ecallantide armDrug
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
| Study group | Role | What they receive |
|---|---|---|
| ecallantide 10mg | Active comparator | Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. Receives: Drug: ecallantide 10 mg; Drug: placebo match for 10 mg ecallantide arm |
| placebo | Placebo comparator | Administered as two SC 3 mL injections Receives: Drug: placebo |
| ecallantide 60mg | Active comparator | Administered as two 3 mL SC injections, each containing 30 mg ecallantide Receives: Drug: ecallantide 60 mg |
| ecallantide 30mg | Active comparator | Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo. Receives: Drug: ecallantide 30 mg; Drug: placebo match for 30 mg ecallantide arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (1)
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".
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study start1 Jun 2011
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
Why it stopped: Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACE Inhibitor Induced AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343823
- Sponsor's protocol ID
- DX-88/27
- Status last verified
- May 2021
- First submitted
- 27 Apr 2011
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25182544
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
- ClinicalTrials.gov ID
- NCT01343823
- Acronym / sponsor ID
- DX-88/27
- Conditions
- ACE Inhibitor Induced Angioedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Posted 18 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ecallantide 10mg | Active comparator | Drug: ecallantide 10 mg, Drug: placebo match for 10 mg ecallantide armAdministered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. |
| placebo | Placebo comparator | Drug: placeboAdministered as two SC 3 mL injections |
| ecallantide 60mg | Active comparator | Drug: ecallantide 60 mgAdministered as two 3 mL SC injections, each containing 30 mg ecallantide |
| ecallantide 30mg | Active comparator | Drug: ecallantide 30 mg, Drug: placebo match for 30 mg ecallantide armAdministered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ecallantide 60 mgAdministered as two 3 mL SC injections, each containing 30 mg ecallantide | Drug | ecallantide 60mg |
| ecallantide 30 mgAdministered as one 3 mL SC injection containing 30 mg ecallantide | Drug | ecallantide 30mg |
| ecallantide 10 mgAdministered as one 3 mL SC injection containing 10 mg ecallantide. | Drug | ecallantide 10mg |
| placeboAdministered as two SC 3 mL injections | Drug | placebo |
| placebo match for 30 mg ecallantide armOne 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm. | Drug | ecallantide 30mg |
| placebo match for 10 mg ecallantide armOne 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm. | Drug | ecallantide 10mg |
Primary outcome
Safety and Efficacy of Ecallantide
Time frame: 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
1 secondary outcome
Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25182544Lewis 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.
Related trials for ACE Inhibitor Induced Angioedema
RecruitingObservational study
Angioedema Biomarker Research Study
Angioedema, Angioedemas, Hereditary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ecallantide 60 mg, ecallantide 30 mg and ecallantide 10 mg in people with ACE Inhibitor Induced Angioedema, run by Shire at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of Ecallantide (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.