Status:
RECRUITING
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Syneos Health
Conditions:
Atypical Hemolytic-Uremic Syndrome
Eligibility:
All Genders
Brief Summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
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.
Eligibility Criteria
Inclusion
- 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
- 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 \[IRB/IEC\]).
Key Trial Info
Start Date :
March 18 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01522183
Start Date
March 18 2013
End Date
January 1 2031
Last Update
September 16 2025
Active Locations (141)
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1
Clinical Trial Site
Aurora, Colorado, United States, 80045
2
Clinical Trial Site
Washington D.C., District of Columbia, United States, 20007
3
Clinical Trial Site
Gainesville, Florida, United States, 32610
4
Clinical Trial Site
Atlanta, Georgia, United States, 30322