Status:
COMPLETED
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Genetic Disorders
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in pat...
Eligibility Criteria
Inclusion
- Main inclusion Criteria:
- Clinical and laboratory diagnosis of HAE
- Plasma level of functional C1INH of less than 50% of normal
- Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.
- Main exclusion Criteria:
- Acquired angioedema
- Pregnancy or breastfeeding
- Participation in another clinical study within prior 3 months
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00262288
Start Date
April 1 2004
End Date
January 1 2007
Last Update
February 22 2013
Active Locations (1)
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1
For information on sites in Europe, please contact Pharming Technologies.
Leiden, Netherlands, 2333 CN