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

August 16, 2023 updated by: Alexion
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female patients of any age who have been diagnosed with aHUS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Through 26 weeks

Secondary Outcome Measures

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).
Time Frame: Through 26 weeks
Through 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2009

Primary Completion (Actual)

November 30, 2010

Study Completion (Actual)

November 30, 2010

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimated)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C09-001r

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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