Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
STEC-HUS
An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
2 other identifiers
interventional
198
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 3, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 5, 2013
April 1, 2013
6 months
August 3, 2011
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Interventions
Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Known complement regulatory mutation or family history of complement regulatory mutation
- Unresolved systemic meningococcal disease
- \. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Bielefeld, 33615, Germany
Unknown Facility
Bielefeld, 33617, Germany
Unknown Facility
Bonn, 53127, Germany
Unknown Facility
Bremen, 28177, Germany
Unknown Facility
Bremerhaven, 27574, Germany
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Essen, 45147, Germany
Unknown Facility
Flensburg, 24939, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Hamburg, 22291, Germany
Unknown Facility
Hamburg, 22359, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Karlsruhe, 76133, Germany
Unknown Facility
Lübeck, 23538, Germany
Unknown Facility
Magdeburg, 39120, Germany
Unknown Facility
Munich, 80804, Germany
Unknown Facility
München, 81377, Germany
Unknown Facility
Münster, 48149, Germany
Unknown Facility
Oldenburg, 26133, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Wildeshausen, 27793, Germany
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2011
First Posted
August 5, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2012
Study Completion
June 1, 2012
Last Updated
April 5, 2013
Record last verified: 2013-04