NCT01410916

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

An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Shiga-like Toxin-producing Escherichia Coli

Interventions

Type	Name	Description
DRUG	Eculizumab (Soliris®)	Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2011-08-05
• Last updated: 2013-04-05

Locations

22 sites across 1 country: Germany