Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
ConditionAtypical Hemolytic-Uremic Syndrome
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
This trial does not accept healthy volunteersQualifiers
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 population
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)
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of patients who experience specified events
To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
Time frame
10 years2
Time to first and subsequent occurrence of specified events.
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
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alexion Pharmaceuticals, Inc.
Lead sponsor
Syneos Health
Collaborator
Source ClinicalTrials.gov