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

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Disease Information

Descriptive Information
Brief Title † C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
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 Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
Secondary Outcome Measure † Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
Condition † Hereditary Angioedema
Intervention † DrugC1 Esterase Inhibitor
Study Arms / Comparison Groups C1 Esterase Inhibitor
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 57
Start Date † August 2005
Completion Date May 2010
Primary Completion Date February 2010
Eligibility Criteria † Key Inclusion Criteria: - Documented congenital C1-INH deficiency - Acute HAE attack - Participation in base study CE1145_3001 (NCT00168103) Key Exclusion Criteria: - Acquired angioedema - Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
Gender Both
Ages 6 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00292981
Organization ID CE1145_3003
Secondary IDs †† 1453
Responsible Party Sponsor
Study Sponsor † CSL Behring
Collaborators ††
Investigators † Study Director: Program Director, CSL Behring
Information Provided By
Verification Date October 2011
First Received Date † February 15, 2006
Last Updated Date March 30, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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