Overview

Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alexion Pharmaceuticals
Treatments:
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