Clinical Trial: A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE"
Brief Summary: Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").
Detailed Summary:
Sponsor: Pharming Technologies B.V.
Current Primary Outcome: HAE Attacks/Week [ Time Frame: 8 weeks ]
Original Primary Outcome: to evaluate the occurrence of HAE attacks under prophylactic administration of rC1INH (50 U/Kg, once a week)
Current Secondary Outcome: The Evaluation of Pharmacokinetic/ Pharmacodynamic ("PK/PD")Parameters. [ Time Frame: 8 weeks ]
Original Secondary Outcome: to evaluate the pK parameters, safety and immunogenicity on repeated administration of rC1INH
Information By: Pharming Technologies B.V.
Dates:
Date Received: February 25, 2009
Date Started: June 2009
Date Completion:
Last Updated: December 20, 2012
Last Verified: December 2012