Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
Study Identifier:
ECU-aHUS-403
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Atypical Hemolytic Uremic Syndrome
Study Drug
Date
Nov 2015 - Oct 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Currently receiving eculizumab treatment in the M11-001 aHUS Registry
- Two normal platelet counts at least 4 weeks apart
- Two normal lactate dehydrogenase levels at least 4 weeks apart
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures
- 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
- Any prior eculizumab treatment discontinuation
- On chronic dialysis (defined as ≥3 months on dialysis)
- Currently participating in another complement inhibitor trial
- Life expectancy of \<6 months
- 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)
Sex
Female & Male
Age
N/A
Study Details
Medical Condition
- Atypical Hemolytic Uremic Syndrome
Study Drug
Date
Nov 2015 - Oct 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Currently receiving eculizumab treatment in the M11-001 aHUS Registry
- Two normal platelet counts at least 4 weeks apart
- Two normal lactate dehydrogenase levels at least 4 weeks apart
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures
- 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
- Any prior eculizumab treatment discontinuation
- On chronic dialysis (defined as ≥3 months on dialysis)
- Currently participating in another complement inhibitor trial
- Life expectancy of \<6 months
- 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)
Protocol Summary
This was a prospective, open-label study with no participant randomization. Treatment for aHUS was observational and at the discretion of the treating physician. The purpose of this study was to assess disease manifestations of complement-mediated thrombotic microangiopathy (TMA) and evaluate potential clinical predictors of disease manifestations and progression in participants with aHUS with or without eculizumab treatment in the clinical setting.
Trial Locations
Location
Status
Location
Clinical Trial Site
Washington D.C., District of Columbia, United States, 20007
Status
N/A
Location
Clinical Trial Site
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Clinical Trial Site
Chicago, Illinois, United States, 60611
Status
N/A
Location
Clinical Trial Site
Boston, Massachusetts, United States, 02115
Status
N/A
Location
Clinical Trial Site
Hackensack, New Jersey, United States, 07601
Status
N/A
Location
Clinical Trial Site
Charlotte, North Carolina, United States, 28203
Status
N/A
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