Clinical Trial: Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study
Brief Summary: The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH
Detailed Summary:
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome:
- Acceptable safety (adverse events [AEs], labs, electrocardiograms [ECGs], vital signs)
- Primary surrogate of efficacy endpoint is hemolysis measured by LDH area under the curve.
Original Primary Outcome: Acceptable safety (AEs, labs, ECGs, vital signs)
Current Secondary Outcome:
- Hemolysis measured by the change of LDH from baseline;
- Quality of Life
Original Secondary Outcome:
- Hemolysis
- Quality of Life
Information By: Alexion Pharmaceuticals
Dates:
Date Received: July 19, 2005
Date Started: December 2004
Date Completion: November 2006
Last Updated: February 20, 2007
Last Verified: February 2007