aHUS Observational Long Term Follow-Up
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Other
- Study Primary Completion Date: January 2017
Clinical Trial Outcome Measures
Primary Measures
- 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.
Secondary Measures
- 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.
Participating in This Clinical Trial
Inclusion Criteria
- aHUS patients who participated in any one of the aHUS-eculizumab clinical studies. – aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database. Exclusion Criteria:
- Not applicable.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Provider of Information About this Clinical Study
- Sponsor
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