Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Last updated: February 20, 2013
Sponsor: Pharming Technologies B.V.
Overall Status: Completed

Phase

2/3

Condition

Hereditary Angioedema

Allergy

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT00225147
C1 1205-01
  • Ages > 12
  • All Genders

Study Summary

Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Funding Source - FDA OOPD

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Clear clinical and laboratory diagnosis of HAE

  • Plasma level of functional C1INH of less than 50% of normal

  • Acute abdominal, urogenital, peripheral, and/or oro-facial/pharyngeal/laryngeal HAEattack

Exclusion

Main Exclusion Criteria:

  • Acquired angioedema

  • Pregnancy or breastfeeding

  • Treatment with any investigational drug within prior 30 days

  • Body weight >120 kg

Study Design

Total Participants: 77
Study Start date:
July 01, 2005
Estimated Completion Date:
January 31, 2010

Study Description

A prospectively planned interim analysis will be performed on the double-blind data.

Connect with a study center

  • For information on sites please contact Pharming Medical Affairs Department

    Leiden, 2300 AL
    Netherlands

    Site Not Available

  • University of California

    Los Angeles, California 90095
    United States

    Site Not Available

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

    Tampa, Florida 33613
    United States

    Site Not Available

  • For information on sites in the USA and Canada, please contact Pharming Healthcare

    DeForest, Wisconsin 53532
    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.