Clinical Trial: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.
Detailed Summary:
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome: Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events. [ Time Frame: Through 26 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA). [ Time Frame: Through 26 weeks ]
Original Secondary Outcome: Same as current
Information By: Alexion Pharmaceuticals
Dates:
Date Received: November 13, 2012
Date Started: August 2009
Date Completion:
Last Updated: January 16, 2013
Last Verified: August 2009