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)

Sponsors

Lead Sponsor: Alexion Pharmaceuticals

Source Alexion Pharmaceuticals
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.

Overall Status Completed
Start Date August 2009
Completion Date November 2010
Primary Completion Date November 2010
Study Type Observational
Primary Outcome
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 Outcome
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
Enrollment 30
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
| Dunwoody, Georgia, United States
| Chicago, Illinois, United States
| Portland, Maine, United States
| Boston, Massachusetts, United States
| Durham, North Carolina, United States
| Cincinnati, Ohio, United States
| Oklahoma City, Oklahoma, United States
| Corpus Christi, Texas, United States
| Salt Lake City, Utah, United States
| Seattle, Washington, United States
| Spokane, Washington, United States
| Appleton, Wisconsin, United States
| Graz, Austria
| Innsbruck, Austria
| Montreal, Quebec, Canada
| Caen, France
| Le Kremlin Bicetre, France
| Paris, France
| Berlin, Germany
| Heidelberg, Germany
| Amsterdam, Netherlands
| Barcelona, Spain
| Bern, Switzerland
Location Countries

Austria

Canada

France

Germany

Netherlands

Spain

Switzerland

United States

Verification Date

August 2009

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Time Perspective: Retrospective

Source: ClinicalTrials.gov