Clinical Trial: Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)

Brief Summary: Post-marketing safety data on patients treated and untreated with eculizumab.

Detailed Summary: 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.
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alexion Pharmaceuticals

Dates:
Date Received: January 18, 2012
Date Started: April 2012
Date Completion: December 2025
Last Updated: April 27, 2017
Last Verified: April 2017