Overview
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Status:
Completed
Completed
Trial end date:
2012-06-01
2012-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alexion PharmaceuticalsTreatments:
Eculizumab
Shiga Toxins
Criteria
Inclusion Criteria:1. Patient must be willing and able to give written informed consent/Assent.
2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Exclusion Criteria:
1. Known complement regulatory mutation or family history of complement regulatory
mutation
2. Unresolved systemic meningococcal disease
3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients