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

Completed

• Conditions: Atypical Hemolytic Uremic Syndrome (aHUS)

• Registration Number: NCT01770951
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2009-08-31
• Primary Completion: 2010-11-30
• Study Completion: 2010-11-30
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.	Through 26 weeks

Secondary Outcome Measures

Name	Time	Method
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