Clinical Trial: Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Tr

Brief Summary: The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Frequency of All HAE Attacks [ Time Frame: Duration of the study ]

A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.


Original Primary Outcome: The presence or absence of unequivocal beginning of relief of the defining symptom within 4 hours.

Current Secondary Outcome:

Original Secondary Outcome:

  • Change in time to the unequivocal beginning of relief of the defining symptom for subjects who receive multiple treatments.
  • The ability of C1INH-nf concentrate to raise C1INH and C4 levels.
  • Safety will be assessed by the number and severity of adverse experiences, and changes in clinical laboratory safety parameters.


Information By: Shire

Dates:
Date Received: April 17, 2007
Date Started: June 2006
Date Completion:
Last Updated: March 19, 2014
Last Verified: March 2014