Status:
COMPLETED
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Shiga-like Toxin-producing Escherichia Coli
Eligibility:
All Genders
2+ years
Phase:
PHASE2
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Patient must be willing and able to give written informed consent/Assent.
- Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
- Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Exclusion
- Known complement regulatory mutation or family history of complement regulatory mutation
- Unresolved systemic meningococcal disease
- 3\. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01410916
Start Date
July 1 2011
End Date
June 1 2012
Last Update
April 5 2013
Active Locations (22)
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1
Bielefeld, Germany, 33615
2
Bielefeld, Germany, 33617
3
Bonn, Germany, 53127
4
Bremen, Germany, 28177