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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410916

Acronym

STEC-HUS

Enrollment

198

Registered

2011-08-05

Start date

2011-07-31

Completion date

2012-06-30

Last updated

2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shiga-like Toxin-producing Escherichia Coli

Keywords

STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation

Brief 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.

Interventions

DRUGEculizumab (Soliris®)

Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Months to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis	8 weeks	Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026