RecruitingNCT01522183
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Sponsor
Alexion Pharmaceuticals, Inc.
Enrollment
3,000 participants
Start Date
Mar 18, 2013
Study Type
OBSERVATIONAL
Conditions
Summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- 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 \[IRB/IEC\]).
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Locations(141)
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NCT01522183
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