Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01522183|
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : March 27, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Atypical Hemolytic-Uremic Syndrome|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)|
|Actual Study Start Date :||April 30, 2012|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
- 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 or ravulizumab in aHUS patients.
- Time to first and subsequent occurrence of specified events. [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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]).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522183
|Contact: Caroline Collupyfirstname.lastname@example.org|
|Study Director:||Katerina Anokhina, MD||Alexion|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Other Study ID Numbers:||
|First Posted:||January 31, 2012 Key Record Dates|
|Last Update Posted:||March 27, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Atypical Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Blood Platelet Disorders