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

Last updated: June 3, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Allergy

Hives (Urticaria)

Urticaria

Treatment

N/A

Clinical Study ID

NCT00262080
EDEMA3 (DX-88/14)
  • Ages > 10
  • All Genders

Study Summary

The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 10 and older
  • Documented diagnosis of HAE, Type I or II
  • Executed informed consent
  • Presentation for treatment within 8 hours of patient recognition of moderate to severeHAE attack

Exclusion

Exclusion Criteria:

  • Receipt of investigational drug or device, other than DX-88, within 30 days oftreatment
  • Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days oftreatment
  • Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug inducedangioedema
  • Pregnancy or breastfeeding
  • Patients who have received DX-88 within 7 days of presentation for dosing in theDouble-blind Phase

Study Design

Total Participants: 91
Study Start date:
December 31, 2005
Estimated Completion Date:
February 28, 2007

Connect with a study center

  • Institute for Asthma and Allergy

    Wheaton, Maryland 20902
    United States

    Site Not Available

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