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Completed Phase 3 Interventional Results available

Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

ClinicalTrials.gov ID: NCT00457015

Public ClinicalTrials.gov record NCT00457015. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 9:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

Study identification

NCT ID
NCT00457015
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
96 participants

Conditions and interventions

Interventions

  • ecallantide Drug
  • Phosphate Buffer Saline (PBS), pH 7.0 Drug

Drug

Eligibility (public fields only)

Age range
10 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2007
Primary completion
May 31, 2008
Completion
May 31, 2008
Last update posted
Jun 7, 2021

2007 – 2008

United States locations

U.S. sites
42
U.S. states
26
U.S. cities
41
Facility City State ZIP Site status
Aaron J. Davis Scottsdale Arizona 85251
Arkansas Children's Hospital Little Rock Arkansas 72202
Little Rock Allergy & Asthma Clinic Little Rock Arkansas 72205
Alta Bates Comprehensive Cancer Center Berkeley California 94704
Pacific Coast Allergy Crescent City California 95531
Jacob Offenberger Granada Hills California 91344
UCLA David Geffen School of Medicine, Department of Medicine Los Angeles California 90095-1680
Asthma and Allergy Associates, P.C. Colorado Springs Colorado 80907
Christiana Hospital Newark Delaware 19718
Georgetown University Hospital Washington D.C. District of Columbia 20007
University of Miami, General Clinical Research Center Miami Florida 33136
University of South Florida Tampa Florida 33613
Roberson Allergy and Asthma West Palm Beach Florida 33401
Family Allergy & Asthma Center, PC Atlanta Georgia 30342
Allergy Center of Brookstone Columbus Georgia 31904
University Consultants in Allergy and Immunology Chicago Illinois 60612
Muncie Allergy Center Muncie Indiana 47304
Kansas City Allergy & Asthma Overland Park Kansas 66210
Institute for Asthma and Allergy Wheaton Maryland 20902
Brigham and Women's Hospital Chestnut Hill Massachusetts 02467
Asthma and Allergy Institute of Michigan Clinton Township Michigan 48038
Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan 48197
Nevada Access to Research and Education Society Las Vegas Nevada 89102
University of Nevada School of Medicine Reno Nevada 89503
UMDNJ-New Jersey Medical School Newark New Jersey 07103
Allergy Partners of Albuquerque Albuquerque New Mexico 87109
Winthrop University Hospital Mineola New York 11501
Allergy Partners of Western North Carolina Asheville North Carolina 28801
University of Cincinnati Cincinnati Ohio 45267
Optimed Research, LLC Columbus Ohio 43235
Valley Clinical Research Center Easton Pennsylvania 18045
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033
Asthma Allergy and Pulmonary Associates Philadelphia Pennsylvania 19107
Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania 15213
Highlands Allergy and Asthma Center, PC Bristol Tennessee 37620
The Paull Allergy and Asthma Clinic, P.A. Bryan Texas 77802
AARA Research Center Dallas Texas 75231
University of Texas Medical School Galveston Texas 77555-1083
Baylor Clinic, Baylor College of Medicine Houston Texas 77030
University of Utah Salt Lake City Utah 84132-2409
Clinical Research Associates of Tidewater Norfolk Virginia 23507
Puget Sound Allergy, Asthma, & Immunology Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00457015, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2021 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00457015 live on ClinicalTrials.gov.

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