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Recruiting Observational

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

NCT01522183 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2013-03-18
Last updated
2025-09-16

Condition(s) studied

Atypical Hemolytic-Uremic Syndrome

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
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 \[IRB/IEC\]).

Primary outcome measure(s)

  • Proportion of patients who experience specified events — 10 years
    To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
  • Time to first and subsequent occurrence of specified events. — 5 years
    To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab or ravulizumab treatment or other disease management approaches

Trial sites (141)

FacilityCityRegionStatus
Clinical Trial Site Aurora Colorado Recruiting
Clinical Trial Site Washington D.C. District of Columbia Recruiting
Clinical Trial Site Gainesville Florida Recruiting
Clinical Trial Site Atlanta Georgia Recruiting
Clinical Trial Site Chicago Illinois Withdrawn
Clinical Trial Site Boston Massachusetts Recruiting
Clinical Trial Site St Louis Missouri Recruiting
Clinical Trial Site Winston-Salem North Carolina Withdrawn
Clinical Trial Site Columbus Ohio Active Not Recruiting
Clinical Trial Site 1 Westmead New South Wales Recruiting
Clinical Trial Site 2 Westmead New South Wales Recruiting
Clinical Trial Site Cairns Queensland Recruiting
Clinical Trial Site Herston Queensland Recruiting
Clinical Trial Site Woolloongabba Queensland Recruiting
Clinical Trial Site Adelaide South Australia Recruiting
Clinical Trial Site Heidelberg Victoria Recruiting
Clinical Trial Site Parkville Victoria Recruiting
Clinical Trial Site Parkville Victoria Recruiting
Clinical Trial Site Murdoch Western Australia Recruiting
Clinical Trial Site Nedlands Western Australia Active Not Recruiting
Clinical Trial Site Brussels Belgium Active Not Recruiting
Clinical Trial Site Brussels Belgium Recruiting
Clinical Trial Site Brussels Belgium Recruiting
Clinical Trial Site (Adult) Edegem Belgium Recruiting
Clinical Trial Site (Pediatric) Edegem Belgium Recruiting
Clinical Trial Site (pediatric) Ghent Belgium Recruiting
Clinical Trial Site (Adult) Leuven Belgium Recruiting
Clinical Trial Site (pediatric) Leuven Belgium Recruiting
Clinical Trial Site (Adult) Liège Belgium Recruiting
Clinical Trial Site (pediatric) Liège Belgium Recruiting
Clinical Trial Site (adult) Woluwe-Saint-Lambert Belgium Recruiting
Clinical Trial Site (Pediatric) Woluwe-Saint-Lambert Belgium Recruiting
Clinical Trial Site London Ontario Recruiting
Clinical Trial Site Toronto Ontario Recruiting
Clinical Trial Site Montreal Quebec Recruiting
Clinical Trial Site Québec Quebec Recruiting
Clinical Trial Site Odense Denmark Recruiting
Clinical Trial Site 1 Amiens France Recruiting
Clinical Trial Site 2 Amiens France Recruiting
Clinical Trial Site Angers France Recruiting

+ 101 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01522183 on ClinicalTrials.gov ↗ ← All trials in Italy