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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: ACE Inhibitor Induced Angioedema

In brief

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

Key facts

Study ID

NCT01343823

Run by

Shire

People needed

79

Starts

2011-06-01

Expected to finish

2012-06-01

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Er Med, Llc — Montgomery, Alabama, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• University of California Los Angeles School of Medicine — Los Angeles, California, United States
• University of California San Diego Mecial Center — San Diego, California, United States
• Christiana Hospital, Department of Emergency Medicine — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• DeKalb Medical — Decatur, Georgia, United States
• University Consultants in Allergy and Immunology — Chicago, Illinois, United States
• Mercy Hospital and Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States
• Beaumont Hospital, Troy — Troy, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nevada Acess to Research and Education Study — Las Vegas, Nevada, United States
• Kings County Hospital Center — Brooklyn, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Staten Island University Hospital — Staten Island, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• The MetroHealth System — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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