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

Alexion Pharmaceuticals, Inc.30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atypical Hemolytic Uremic Syndrome (aHUS)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (23)

Unnamed facility

Dunwoody, Georgia, United States

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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