aHUS Observational Long Term Follow-Up (LTFU)
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.
Atypical Hemolytic Uremic Syndrome
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only|
|Target Follow-Up Duration:||5 Years|
|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 Study|
- TMA complication-free survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.
- Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention [ Time Frame: 5 Years ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522170
|United States, Indiana|
|Fort Wayne, Indiana, United States|