Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

Last updated: May 13, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Allergy

Urticaria

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT02586805
DX-2930-03
2015-003943-20
  • Ages > 12
  • All Genders

Study Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females 12 years of age or older at time of screening
  • Documented diagnosis of HAE, Type I or II
  • Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
  • Adult subjects and caregivers of subjects under the age of 18 are willing and able toread, understand, and sign an informed consent form. Subjects age 12 to 17, whosecaregiver provides informed consent, are willing and able to read, understand an dsignan assent form.
  • Males and femailes who are fertile and sexually active must adhere to contraceptionrequirements.

Exclusion

Exclusion Criteria:

  • Concomitant diagnosis of another form of chronic, recurrent angioedema, such asacquired angioedema, idiopathic angioedema, or recurrent angioedema associated withurticaria.
  • Participation in a prior DX-2930 study
  • Treatment with any other investigational drug or exposure to an investigational devicewithin 4 weeks prior screening
  • Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containingmedications within 4 weeks prior to screening.
  • Exposure to androgens within 2 weeks prior to entering the run-in period.
  • Use of long-term prophylactic therapy for HAE within 2 weeks prior to entering therun-in period.
  • Use of short-term prophylaxis for HAE within 7 days prior to entering the run-inperiod.
  • Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit ofnormal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevationis a result of Gilbert's syndrome).
  • Pregnancy or breastfeeding.

Study Design

Total Participants: 125
Study Start date:
March 03, 2016
Estimated Completion Date:
April 13, 2017

Connect with a study center

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2V2
    Canada

    Site Not Available

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario K1G 6C6
    Canada

    Site Not Available

  • Gordon Sussman Clinical Research Inc.

    Toronto, Ontario M4V 1R2
    Canada

    Site Not Available

  • Université de Montréal

    Montreal, Quebec H2W 1T8
    Canada

    Site Not Available

  • Clinique Specialisee en Allergie de la Capitale

    Quebec City, Quebec G1V 4M6
    Canada

    Site Not Available

  • Charité - University of Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Hautklinik und Poliklinik der Universitätsmedizin

    Mainz, 55131
    Germany

    Site Not Available

  • HZRM Hamophilie-Zentrum Rhein Main

    Morfelden-Walldorf, 64546
    Germany

    Site Not Available

  • Hospital L. Sacco, Milan University

    Milan, 20157
    Italy

    Site Not Available

  • Triumpharma

    Amman, 11941
    Jordan

    Site Not Available

  • Sociedad Alergologica

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Barts Health NHS Trust Clinical Research Centre

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Medical Research of Arizona

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • UC San Diego School of Medicine

    La Jolla, California 92093
    United States

    Site Not Available

  • UC San Diego School of Medicine

    San Diego, California 92122
    United States

    Site Not Available

  • AIRE Medical of Los Angeles

    Santa Monica, California 90404
    United States

    Site Not Available

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • IMMUNOe International Health & Research Centers

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Asthma and Allergy Associates, P.C.

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Yale Allergy and Immunology Center

    North Haven, Connecticut 06473
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33613
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Breathe America

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Institute of Asthma & Allergy, P.C.

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02421
    United States

    Site Not Available

  • University of Michigan Hospital and Health System

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Midwest Immunology Clinic

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Hudson-Essex Allergy, LLC

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Allergy, Asthma and Immunology

    Fair Lawn, New Jersey 07410
    United States

    Site Not Available

  • Atlantic Research Center, LLC

    Ocean, New Jersey 07712
    United States

    Site Not Available

  • Atlantic Research Center, LLC

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • The Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • American Health Research

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Duke Asthma, Allergy and Airway Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Cleveland Clinic Family Health Center - Independence

    Cleveland, Ohio 44131
    United States

    Site Not Available

  • Optimed Research, LTD

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Toledo Institute of Clinical Research

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Allergy Clinic of Tulsa, Inc.

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Austin Regional Clinic

    Austin, Texas 78731
    United States

    Site Not Available

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Intermountain Clinical Research

    Draper, Utah 84020
    United States

    Site Not Available

  • Allergy Associates of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Marycliff Allergy Specialists

    Spokane, Washington 99202
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.