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