Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
NCT ID: NCT01410916
Last Updated: 2013-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
198 participants
INTERVENTIONAL
2011-07-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Eculizumab (Soliris®)
Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously
Eligibility Criteria
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Inclusion Criteria
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
2. Unresolved systemic meningococcal disease
3. 3\. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
2 Months
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Bielefeld, , Germany
Bielefeld, , Germany
Bonn, , Germany
Bremen, , Germany
Bremerhaven, , Germany
Cologne, , Germany
Essen, , Germany
Flensburg, , Germany
Göttingen, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Karlsruhe, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Munich, , Germany
München, , Germany
Münster, , Germany
Oldenburg, , Germany
Ulm, , Germany
Wildeshausen, , Germany
Countries
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Other Identifiers
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2011-002691-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C11-001
Identifier Type: -
Identifier Source: org_study_id
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