Status:
COMPLETED
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
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, espe...
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 f...
Eligibility Criteria
Inclusion
- Key
- Documented congenital C1-INH deficiency
- Acute facial or abdominal HAE attack
- Key
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00168103
Start Date
June 1 2005
End Date
December 1 2007
Last Update
March 31 2015
Active Locations (36)
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1
Study Site
Granada Hills, California, United States, 91344
2
Study Site
Weston, Florida, United States, 33331
3
Study Site
Atlanta, Georgia, United States, 30342
4
Study Site
Idaho Falls, Idaho, United States, 83404