Completed

NCT Number: NCT01410916

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

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.

Completed

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Key information

Conditions

Shiga-like Toxin-producing Escherichia Coli

Age range

2 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bielefeld, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient must be willing and able to give written informed consent/Assent.
Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Exclusion criteria

Known complement regulatory mutation or family history of complement regulatory mutation
Unresolved systemic meningococcal disease
3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Treatment and study plan

Eculizumab (Soliris®)

Drug

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: STEC-HUS

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Aug 5, 2011
Registry last updated: Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.