Clinical Trial: C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

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

Official Title: Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks

Brief 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.

Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome:

  • Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) [ Time Frame: Up to 24 h after start of study treatment ]
    The start of symptom relief was determined by subject self-assessment.
  • Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) [ Time Frame: Up to 24 h after start of study treatment ]
    The start of symptom relief was determined by subject self-assessment.


Original Primary Outcome: Onset of relief of symptoms from hereditary angioedema (HAE) attack

Current Secondary Outcome:

  • Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) [ Time Frame: Up to Day 9 following an attack ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
  • Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) [ Time Frame: Up to Day 9 following an attack ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.


Original Secondary Outcome: Time between start of study medication administration and complete resolution of all symptoms of the HAE attack

Information By: CSL Behring

Dates:
Date Received: February 15, 2006
Date Started: August 2005
Date Completion:
Last Updated: April 20, 2015
Last Verified: October 2011