Atypical Hemolytic Uremic Syndrome
Conditions
Keywords
Atypical Hemolytic Uremic Syndrome, aHUS, Eculizumab
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.
Interventions
None listed
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TMA complication-free survival | 5 Years | Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention | 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. |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed