Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAlexion Pharmaceuticals, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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]).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

141
Australia
Clinical Trial Site 12145, WestmeadNew South Wales, Australia
Clinical Trial Site 22145, WestmeadNew South Wales, Australia
Clinical Trial Site4870, CairnsQueensland, Australia
Clinical Trial Site4029, HerstonQueensland, Australia

Sponsors and collaborators

Alexion Pharmaceuticals, Inc.

Lead sponsor

Syneos Health

Collaborator