Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Purpose

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Condition

  • Atypical Hemolytic-Uremic Syndrome

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female patients of any age, including minors, who have been diagnosed with aHUS - Patients with or without an identified complement pathogenic variant or anti-complement factor antibody - Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)]. - ADAMTS13 > 5%, if performed.

Exclusion Criteria

  • Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC). - Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]).

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Other

Recruiting Locations

Clinical Trial Site
Aurora 5412347, Colorado 5417618 80045
Contact:
Dixon

Clinical Trial Site
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Broome

Clinical Trial Site
Gainesville 4156404, Florida 4155751 32610
Contact:
Segal

Clinical Trial Site
Atlanta 4180439, Georgia 4197000 30322
Contact:
Greenbaum

Clinical Trial Site
Boston 4930956, Massachusetts 6254926 02115
Contact:
Alenizi

Clinical Trial Site
St Louis 4407066, Missouri 4398678 63110
Contact:
Majerus

More Details

NCT ID
NCT01522183
Status
Recruiting
Sponsor
Alexion Pharmaceuticals, Inc.

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
1-855-752-2356
clinicaltrials@alexion.com

Detailed Description

The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.