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

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ClinicalTrials.gov Identifier: NCT01770951
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Atypical Hemolytic Uremic Syndrome (aHUS)

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Retrospective
Official Title: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Study Start Date : August 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients of any age who have been diagnosed with aHUS.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770951


  Hide Study Locations
Locations
United States, Georgia
Dunwoody, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maine
Portland, Maine, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
Corpus Christi, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
United States, Wisconsin
Appleton, Wisconsin, United States
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
Sponsors and Collaborators
Alexion Pharmaceuticals

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01770951     History of Changes
Other Study ID Numbers: C09-001r
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: August 2009

Additional relevant MeSH terms:
Syndrome
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Disease
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders