Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment

Launched by ALEXION PHARMACEUTICALS, INC. · Nov 24, 2015

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Currently receiving eculizumab treatment in the M11-001 aHUS Registry
• • 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:
• • 1. Any prior eculizumab treatment discontinuation
• • 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)