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
16+ years
Phase:
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
- Clear clinical and laboratory diagnosis of HAE
- Baseline plasma level of functional C1INH of less than 50% of normal
- Evidence for exacerbation or development of a severe abdominal, oro-facial/ pharyngeal/ laryngeal, genito-urinary and/or peripheral HAE attack
Exclusion
- Acquired angioedema
- Pregnancy or breastfeeding
- Participation in another clinical study within prior 3 months
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00262301
Start Date
June 1 2004
End Date
October 1 2009
Last Update
October 2 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
For information on sites, please contact Pharming Medical Affairs Deparment
Leiden, Netherlands, 2300 AL
2
Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department
Târgu Mureş, Romania, 541103