Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

Last updated: May 14, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Urticaria

Allergy

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT00456508
DX-88/19
  • Ages > 10
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 10 years of age or older
  • Documented diagnosis of HAE (Type I or II)
  • Willing and able to give informed consent
  • Acute HAE attack at time of presentation

Exclusion

Exclusion Criteria:

  • Receipt of an investigational drug or device, within 30 days prior to study treatment,other than DX-88 (ecallantide)
  • Pregnancy or breastfeeding
  • Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
  • Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) isoffered

Study Design

Total Participants: 147
Study Start date:
April 01, 2007
Estimated Completion Date:
September 01, 2010

Study Description

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Connect with a study center

  • Allergy and Asthma Research Centre

    Ottawa, Ontario K1Y 4G2
    Canada

    Site Not Available

  • Jordan University Hospital

    Amman, 1194
    Jordan

    Site Not Available

  • Aaron Davis

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Little Rock Allergy & Asthma Clinic

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California 94704
    United States

    Site Not Available

  • Pacific Coast Allergy

    Crescent City, California 95531
    United States

    Site Not Available

  • Jacob Offenberger

    Granada Hills, California 91344
    United States

    Site Not Available

  • UCLA David Geffen School of Medicine, Department of Medicine

    Los Angeles, California 90095-1680
    United States

    Site Not Available

  • Asthma and Allergy Associates, P.C.

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Christiana Hospital, Christiana Care Health Services

    Newark, Delaware 19718
    United States

    Site Not Available

  • Georgetown University Medical Center, Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • University of Miami, General Clinical Research Center

    Miami, Florida 33136
    United States

    Site Not Available

  • University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit

    Tampa, Florida 33613
    United States

    Site Not Available

  • Roberson Allergy and Asthma

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Family Allergy & Asthma Center, PC

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Allergy Center of Brookstone

    Columbus, Georgia 31904
    United States

    Site Not Available

  • University Consultants in Allergy and Immunology

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Muncie Allergy Center

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Kansas City Allergy & Asthma

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Institute for Asthma and Allergy

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • Asthma and Allergy Institutes of Michigan

    Clinton TWP, Michigan 48038
    United States

    Site Not Available

  • Asthma and Allergy Institutes of Michigan

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Nevada Access to Research and Education Society

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • University of Nevada School of Medicine

    Reno, Nevada 89503
    United States

    Site Not Available

  • UMDNJ- New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Allergy Partners of Albuquerque

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • University of Cincinnati, Division of Internal Medicine

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Optimed Research, LLC

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Asthma Allergy and Pulmonary Associates

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Highlands Allergy and Asthma Center, PC

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • The Paull Allergy and Asthma Clinic, P.A

    Bryan, Texas 77802
    United States

    Site Not Available

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Utah Health Sciences Center

    Salt Lake City, Utah 84132-2409
    United States

    Site Not Available

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Puget Sound Allergy, Asthma, & Immunology

    Tacoma, Washington 98405
    United States

    Site Not Available

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