ACE Inhibitor Induced Angioedema Clinical Trial
Official title:
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
| NCT number | NCT01343823 |
| Other study ID # | DX-88/27 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | June 1, 2011 |
| Est. completion date | June 1, 2012 |
| Verified date | May 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
| Status | Terminated |
| Enrollment | 79 |
| Est. completion date | June 1, 2012 |
| Est. primary completion date | June 1, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Georgia Health Sciences University | Augusta | Georgia |
| United States | University Medical Center Brackenridge | Austin | Texas |
| United States | Kings County Hospital Center | Brooklyn | New York |
| United States | St Joseph Regional Health Center | Bryan | Texas |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Mercy Hospital and Medical Center | Chicago | Illinois |
| United States | University Consultants in Allergy and Immunology | Chicago | Illinois |
| United States | The MetroHealth System | Cleveland | Ohio |
| United States | Arrowhead Regional Medical Center | Colton | California |
| United States | The Ohio State University Medical Center | Columbus | Ohio |
| United States | University Hospital East | Columbus | Ohio |
| United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | DeKalb Medical | Decatur | Georgia |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Emergency Medicine Residency Program | Fort Worth | Texas |
| United States | 301 University Blvd. | Galveston | Texas |
| United States | East Carolina University | Greenville | North Carolina |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Nevada Acess to Research and Education Study | Las Vegas | Nevada |
| United States | University of California Los Angeles School of Medicine | Los Angeles | California |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | Er Med, Llc | Montgomery | Alabama |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Christiana Hospital, Department of Emergency Medicine | Newark | Delaware |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | Beaumont Hospital, Royal Oak | Royal Oak | Michigan |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of California San Diego Mecial Center | San Diego | California |
| United States | Staten Island University Hospital | Staten Island | New York |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Beaumont Hospital, Troy | Troy | Michigan |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 hours | |
| Secondary | 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". | 6 hours |