A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
1 other identifier
observational
30
8 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2009
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2010
CompletedFirst Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedAugust 18, 2023
August 1, 2023
1.2 years
November 13, 2012
August 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.
Through 26 weeks
Secondary Outcomes (1)
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).
Through 26 weeks
Eligibility Criteria
Male or female patients of any age who have been diagnosed with aHUS.
You may qualify if:
- Male or female patients of any age who have been diagnosed with aHUS.
- Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.
You may not qualify if:
- \. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Dunwoody, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Portland, Maine, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Appleton, Wisconsin, United States
Unknown Facility
Graz, Austria
Unknown Facility
Innsbruck, Austria
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Caen, France
Unknown Facility
Le Kremlin-Bicêtre, France
Unknown Facility
Paris, France
Unknown Facility
Berlin, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Barcelona, Spain
Unknown Facility
Bern, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2012
First Posted
January 18, 2013
Study Start
August 31, 2009
Primary Completion
November 30, 2010
Study Completion
November 30, 2010
Last Updated
August 18, 2023
Record last verified: 2023-08