Clinical Trial: Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH
Brief Summary: The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.
Detailed Summary:
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome: Treatment-emergent adverse events [ Time Frame: during study up to 30 days post last study drug dosing ]
Original Primary Outcome:
Current Secondary Outcome:
- Incidence of thrombosis [ Time Frame: during study up to 16 weeks post study drug dosing ]
- Hemolysis as measured by LDH area under the curve [ Time Frame: during study ]
- Quality of Life as measured by FACIT-F SCALE [ Time Frame: during study ]
Original Secondary Outcome:
Information By: Alexion Pharmaceuticals
Dates:
Date Received: July 20, 2005
Date Started: May 2005
Date Completion:
Last Updated: January 14, 2009
Last Verified: January 2009
