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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Shiga-like Toxin-producing Escherichia Coli

Treatments: Drug: Eculizumab (Soliris®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410916

C11-001

2011-002691-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 2+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)