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Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks

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Disease Information

Descriptive Information
Brief Title † Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
Official Title † Human Pasteurized C1 Esterase Inhibitor Concentrate (CE1145) in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks
Brief Summary HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.
Detailed Description For each subject, only a single abdominal or facial attack was treated and evaluated. After receiving treatment, subjects were observed for a minimum of 4 hours, after which they could be discharged from the study center if they reported onset of symptom relief. Starting from 4 hours after treatment, subjects who reported insufficient or no symptom relief could receive a second dose of double-blind treatment (called "rescue medication") as follows: C1-INH 20 U/kg bw for subjects initially receiving placebo, C1-INH 10 U/kg bw for subjects initially receiving C1-INH 10 U/kg bw, and placebo for subjects initially receiving C1-INH 20 U/kg bw. The study was defined to be successful if the primary outcome measure and at least one of the secondary outcome measures were met in the comparison between the C1-INH 20 U/kg bw group and the Placebo group.
Study Phase Phase 2/Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Time to Start of Relief of Symptoms From HAE Attack
Secondary Outcome Measure † Number of Subjects With Worsened Intensity of Clinical HAE Symptoms
Condition † Hereditary Angioedema
Intervention † BiologicalC1 Esterase Inhibitor
Study Arms / Comparison Groups C1-INH 10 U/kg bw 10 Units (U)/kg body weight (bw) dose C1-INH 20 U/kg bw 20 U/kg bw dose Placebo
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 † Biological
Estimated Enrollment † 126
Start Date † June 2005
Completion Date December 2007
Primary Completion Date October 2007
Eligibility Criteria † Key Inclusion Criteria: - Documented congenital C1-INH deficiency - Acute facial or abdominal HAE attack Key Exclusion Criteria: - Acquired angioedema - Treatment with any other investigational drug within the last 30 days before study entry - Treatment with any C1-INH concentrate within the previous 7 days
Gender Both
Ages 6 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00168103
Organization ID CE1145_3001
Secondary IDs †† 2004-001186-17
Responsible Party
Study Sponsor † CSL Behring
Collaborators ††
Investigators † Study Director: Program Director, Clinical R&D, CSL Behring
Information Provided By
Verification Date February 2011
First Received Date † September 12, 2005
Last Updated Date February 10, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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