Clinical Trial: aHUS Observational Long Term Follow-Up

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational [Patient Registry]

Official Title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical

Brief Summary: There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

Detailed Summary:
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome: TMA complication-free survival [ Time Frame: 5 Years ]

Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.


Original Primary Outcome: Same as current

Current Secondary Outcome: Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention [ Time Frame: 5 Years ]

Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events.


Original Secondary Outcome: Same as current

Information By: Alexion Pharmaceuticals

Dates:
Date Received: January 18, 2012
Date Started: March 2012
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017