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Eculizumab in Japanese Patients With aHUS
NCT01757431Phase 2
Key facts
- Status
- Completed
- Start
- May 2012
- Primary completion
- Sep 2013
- Countries
- 1
- Sponsor
- Alexion Pharmaceuticals
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- eculizumab
- Conditions
- atypical hemolytic uremic syndrome (aHUS)
01
Overview
Phase 2, open-label, single-arm trial of eculizumab in atypical hemolytic uremic syndrome (aHUS), sponsored by Alexion Pharmaceuticals. Primary endpoint: Adverse events and serious adverse events at 12 weeks. Started May 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ECULIZUMAB
Patients receiving Eculizumab
03
Who it enrols
Patients with aHUS who are either currently receiving eculizumab or are newly diagnosed/presenting with clinical manifestations. New patients must have signs of hemolysis and renal impairment. Excludes patients with STEC-HUS, drug-related HUS, infection-related HUS, or other known etiologies of HUS.
04
Endpoints
Primary
Adverse events and serious adverse events
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