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Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

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ClinicalTrials.gov Identifier: NCT01522183
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : February 20, 2018
INC Research
Information provided by (Responsible Party):
Alexion Pharmaceuticals

January 18, 2012
January 31, 2012
February 20, 2018
April 2012
December 2023   (Final data collection date for primary outcome measure)
  • Proportion of patients who experience specified events [ Time Frame: 10 years ]
    To collect and evaluate safety and effectiveness data specific to the use of eculizumab in aHUS patients.
  • Time to first and subsequent occurrence of specified events. [ Time Frame: 10 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 treatment or other disease management approaches
Same as current
Complete list of historical versions of study NCT01522183 on ClinicalTrials.gov Archive Site
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Not Provided
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Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)
Post-marketing safety data on patients treated and untreated with eculizumab.
The study will capture post-marketing safety data on patients treated with eculizumab. Additionally, the study will collect information on the progression of disease in all patients.
Observational [Patient Registry]
Observational Model: Other
Time Perspective: Other
10 Years
Not Provided
Non-Probability Sample
Male or female patients of any age, including minors, who have been diagnosed with aHUS; clinical diagnosis of aHUS, patients with or without an identified complement regulatory factor genetic abnormality or anti-complement factor antibody, ADAMTS13 > 5% (if performed)
Atypical Hemolytic-Uremic Syndrome
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2025
December 2023   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients of any age, including minors, who have been diagnosed with aHUS
  • 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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact: Project Manager ahus-registry@syneoshealth.com
Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Poland,   United Kingdom,   United States
Not Provided
Plan to Share IPD: No
Alexion Pharmaceuticals
Alexion Pharmaceuticals
INC Research
Study Director: Masayo Ogawa, MD, FAACP Alexion Pharmaceuticals
Alexion Pharmaceuticals
February 2018