Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
NCT ID: NCT02614898
Last Updated: 2020-01-02
Study Results
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View full resultsBasic Information
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TERMINATED
67 participants
OBSERVATIONAL
2015-11-04
2017-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Eculizumab
The targeted population consists of pediatric and adult participants with aHUS who received eculizumab at the discretion of the treating physician.
Eculizumab
This study was an observational study. Therefore, the study drug was not provided as part of this study, and the dosing regimen was based solely at the discretion of the treating physician.
Interventions
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Eculizumab
This study was an observational study. Therefore, the study drug was not provided as part of this study, and the dosing regimen was based solely at the discretion of the treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Two normal platelet counts at least 4 weeks apart
3. Two normal lactate dehydrogenase levels at least 4 weeks apart
4. Willing, committed, and able to return for all clinic visits and complete all study-related procedures
5. Participant or participant's parent/legal guardian must have been willing and able to give written informed consent. Participant (if minor) must have been willing to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees)
Exclusion Criteria
2. On chronic dialysis (defined as ≥3 months on dialysis)
3. Currently participating in another complement inhibitor trial
4. Life expectancy of \<6 months
5. Participant or participant's parent/legal guardian was unable to give written informed consent. Participant (if minor) was unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees)
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Washington D.C., District of Columbia, United States
Clinical Trial Site
Atlanta, Georgia, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Hackensack, New Jersey, United States
Clinical Trial Site
Charlotte, North Carolina, United States
Clinical Trial Site
Columbus, Ohio, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
Adelaide, , Australia
Clinical Trial Site
Clayton, , Australia
Clinical Trial Site
Heidelberg, , Australia
Clinical Trial Site
Kingswood, , Australia
Clinical Trial Site
Liverpool, , Australia
Clinical Trial Site
Nedlands, , Australia
Clinical Trial Site
Parkville, , Australia
Clinical Trial Site
Parkville, , Australia
Clinical Trial Site
Perth, , Australia
Clinical Trial Site
Westmead, , Australia
Clinical Trial Site
Woolloongabba, , Australia
Clinical Trial Site
Hannover, , Germany
Clinical Trial Site
Hanover, , Germany
Clinical Trial Site
Kiel, , Germany
Clinical Trial Site
Lübeck, , Germany
Clinical Trial Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-003135-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ECU-aHUS-403
Identifier Type: -
Identifier Source: org_study_id
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