drugset
drugset / Trial / NCT01410916

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

NCT01410916 ↗

Phase 2/3 Completed 198 enrolled Alexion Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-07
Primary completion
2012-01
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 300 mg Intravenous
Subject Eculizumab Monoclonal antibody 600 mg Intravenous
Subject Eculizumab Monoclonal antibody 900 mg Intravenous
Subject Eculizumab Monoclonal antibody 1200 mg Intravenous

Indications

Shiga toxin-associated hemolytic uremic syndrome