TerminatedNot Applicable

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

Stopped: Terminated for administrative reasons before enrollment was complete.

United States67 participantsStarted 2015-11-04

Plain-language 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.

Who can participate

SexALL

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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)

What they're measuring

Rate Of Thrombotic Microangiopathy (TMA) Manifestations During Eculizumab Treatment Compared To Off-Treatment

Timeframe: Baseline, 24 Months

Trial details

NCT IDNCT02614898

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-10-05

Results submitted2018-05-14

View on ClinicalTrials.gov More Atypical Hemolytic Uremic Syndrome trials