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