C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

Last updated: April 20, 2015
Sponsor: CSL Behring
Overall Status: Completed

Phase

3

Condition

Urticaria

Allergies & Asthma

Allergy

Treatment

N/A

Clinical Study ID

NCT00292981
CE1145_3003
1453
  • Ages > 6
  • All Genders

Study Summary

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Documented congenital C1-INH deficiency

  • Acute HAE attack

  • Participation in base study CE1145_3001 (NCT00168103)

Exclusion

Key Exclusion Criteria:

  • Acquired angioedema

  • Treatment with any other investigational drug besides CE1145 in the last 30 daysbefore study entry

Study Design

Total Participants: 57
Study Start date:
August 01, 2005
Estimated Completion Date:
May 31, 2010

Connect with a study center

  • Contact CSL Behring for facility details

    Ottawa, Ontario KIY 4G2
    Canada

    Site Not Available

  • Contact CSL Behring for facility details

    Weston, Florida 33331
    United States

    Site Not Available

  • Contact CSL Behring for facility details

    Atlanta, Georgia 30342
    United States

    Site Not Available

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    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Contact CSL Behring for facility details

    Chicago, Illinois 60612-3244
    United States

    Site Not Available

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    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Contact CSL Behring for facility details

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Contact CSL Behring for facility details

    Plymouth, Minnesota 55446
    United States

    Site Not Available

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    Omaha, Nebraska 69131
    United States

    Site Not Available

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    Tulsa, Oklahoma 74133
    United States

    Site Not Available

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    Eugene, Oregon 97401
    United States

    Site Not Available

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    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Contact CSL Behring for facility details

    Dallas, Texas 75230
    United States

    Site Not Available

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