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Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Recruiting
years of age
Both
Phase N/A

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Overview

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

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

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 details

Atypical Hemolytic-Uremic Syndrome

NCT01522183

Alexion Pharmaceuticals, Inc.

26 January 2024

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