Back to resultsSafety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS) (STEC-HUS)
Primary Purpose
Shiga-like Toxin-producing Escherichia Coli
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Eculizumab (Soliris®)
Sponsored by
About this trial
This is an interventional treatment trial for Shiga-like Toxin-producing Escherichia Coli focused on measuring STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation
Eligibility Criteria
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
Sites / Locations
Outcomes
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410916
Brief Title
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Acronym
STEC-HUS
Official Title
An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shiga-like Toxin-producing Escherichia Coli
Keywords
STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Eculizumab (Soliris®)
Intervention Description
Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Bielefeld
ZIP/Postal Code
33615
Country
Germany
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Bremen
ZIP/Postal Code
28177
Country
Germany
City
Bremerhaven
ZIP/Postal Code
27574
Country
Germany
City
Essen
ZIP/Postal Code
45147
Country
Germany
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
City
Hamburg
ZIP/Postal Code
22359
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
City
Munchen
ZIP/Postal Code
81377
Country
Germany
City
Munich
ZIP/Postal Code
80804
Country
Germany
City
Munster
ZIP/Postal Code
48149
Country
Germany
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Wildeshausen
ZIP/Postal Code
27793
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
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