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Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema | Clinical Trials | Clareo Health

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

Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

NCT01343823•Shire

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (39)

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

Key Dates

Start Date

June 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

June 11, 2021

Enrollment

ACTUAL participants

Conditions

ACE Inhibitor Induced Angioedema

Interventions

ecallantide 60 mg

DRUG

ecallantide 30 mg

DRUG

ecallantide 10 mg

DRUG

placebo

DRUG

placebo match for 30 mg ecallantide arm

DRUG

placebo match for 10 mg ecallantide arm

DRUG