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

Study Identifier:
C11-001
ClinicalTrials.gov Identifier:
NCT01410916
EudraCT Identifier:
2011-002691-17
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab (Soliris®)
Date
Jul 2011 - Jan 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Sex
Female & Male
Age
2+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab (Soliris®)
Date
Jul 2011 - Jan 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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

Protocol 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.

Trial Locations

Location
Status
Location
Bielefeld, Germany, 33615
Status
N/A
Location
Bielefeld, Germany, 33617
Status
N/A
Location
Bonn, Germany, 53127
Status
N/A
Location
Bremen, Germany, 28177
Status
N/A
Location
Bremerhaven, Germany, 27574
Status
N/A
Location
Cologne, Germany, 50937
Status
N/A
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