Clinical Trials in Italy / NCT01522183
Recruiting
Observational
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
NCT01522183 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Atypical Hemolytic-Uremic Syndrome
Study summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
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 \[IRB/IEC\]).
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Clinical Trial Site | Chicago | Illinois | Withdrawn |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| Clinical Trial Site | Winston-Salem | North Carolina | Withdrawn |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.
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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