Status:
COMPLETED
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Hereditary Angioedema
Angioneurotic Edema
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-th...
Detailed Description
A prospectively planned interim analysis will be performed on the double-blind data.
Eligibility Criteria
Inclusion
- Main
- Clear clinical and laboratory diagnosis of HAE
- Plasma level of functional C1INH of less than 50% of normal
- Acute abdominal, urogenital, peripheral, and/or oro-facial/pharyngeal/laryngeal HAE attack
- Main
Exclusion
- Acquired angioedema
- Pregnancy or breastfeeding
- Treatment with any investigational drug within prior 30 days
- Body weight \>120 kg
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00225147
Start Date
July 1 2005
End Date
January 1 2010
Last Update
February 22 2013
Active Locations (1)
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1
For information on sites please contact Pharming Medical Affairs Department
Leiden, Netherlands, 2300 AL