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Purpose

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

Condition

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.