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

This study has been completed.
Information provided by (Responsible Party):
Alexion Pharmaceuticals Identifier:
First received: August 3, 2011
Last updated: April 4, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Shiga-like Toxin-producing Escherichia Coli
Drug: Eculizumab (Soliris®)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Resource links provided by NLM:

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Enrollment: 198
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Eculizumab (Soliris®)
    Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously

Ages Eligible for Study:   2 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01410916

Bielefeld, Germany, 33615
Bielefeld, Germany, 33617
Bonn, Germany, 53127
Bremen, Germany, 28177
Bremerhaven, Germany, 27574
Essen, Germany, 45147
Flensburg, Germany, 24939
Göttingen, Germany, 37075
Hamburg, Germany, 20246
Hamburg, Germany, 22291
Hamburg, Germany, 22359
Hannover, Germany, 30625
Karlsruhe, Germany, 76133
Köln, Germany, 50937
Lubeck, Germany, 23538
Magdeburg, Germany, 39120
Munchen, Germany, 81377
Munich, Germany, 80804
Munster, Germany, 48149
Oldenburg, Germany, 26133
Ulm, Germany, 89081
Wildeshausen, Germany, 27793
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

Responsible Party: Alexion Pharmaceuticals Identifier: NCT01410916     History of Changes
Other Study ID Numbers: C11-001
2011-002691-17 ( EudraCT Number )
Study First Received: August 3, 2011
Last Updated: April 4, 2013

Keywords provided by Alexion Pharmaceuticals:
Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome
uncontrolled complement activation

Additional relevant MeSH terms:
Hemolytic-Uremic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders
Shiga Toxins
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017