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A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

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ClinicalTrials.gov Identifier: NCT01770951
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

November 13, 2012
January 18, 2013
January 18, 2013
August 2009
November 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
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.
Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Male or female patients of any age who have been diagnosed with aHUS.
Atypical Hemolytic Uremic Syndrome (aHUS)
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients of any age who have been diagnosed with aHUS.
  2. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

Exclusion Criteria:

1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   France,   Germany,   Netherlands,   Spain,   Switzerland,   United States
 
 
NCT01770951
C09-001r
Not Provided
Not Provided
Not Provided
Alexion Pharmaceuticals
Alexion Pharmaceuticals
Not Provided
Not Provided
Alexion Pharmaceuticals
August 2009