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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01770951

Enrollment

Registered

2013-01-18

Start date

2009-08-31

Completion date

2010-11-30

Last updated

2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Austria, Canada, France, Germany, Netherlands, Spain, Switzerland, United States

Outcome results