Trial record 3 of 22 for: "atypical hemolytic-uremic syndrome" OR "Hemolytic-Uremic Syndrome"
Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry
This study is currently recruiting participants.
Verified July 2013 by Alexion Pharmaceuticals
Information provided by (Responsible Party):
First received: January 18, 2012
Last updated: July 9, 2013
Last verified: July 2013
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.
Atypical Hemolytic-Uremic Syndrome
|Official Title:||An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)|
Resource links provided by NLM:
Further study details as provided by Alexion Pharmaceuticals:
Primary Outcome Measures:
- Proportion of patients who experience specified events [ Time Frame: 10 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2025|
|Estimated Primary Completion Date:||December 2023 (Final data collection date for primary outcome measure)|
Contacts and Locations