Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Study Identifier:
M11-001
ClinicalTrials.gov Identifier:
NCT01522183
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
    Date
    Apr 2012 - Jan 2031
    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
    • Male or female patients of any age, including minors, who have been diagnosed with aHUS
    • Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
    • Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\].
    • ADAMTS13 \> 5%, if performed.
    Exclusion Criteria
    • Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
    • Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).
    Sex
    Female & Male
    Age
    N/A

    Study Details

    Medical Condition
    • Unmapped
    Study Drug
      Date
      Apr 2012 - Jan 2031
      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
      • Male or female patients of any age, including minors, who have been diagnosed with aHUS
      • Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
      • Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\].
      • ADAMTS13 \> 5%, if performed.
      Exclusion Criteria
      • Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
      • Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).

      Protocol Summary

      Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

      Trial Locations

      Location
      Status
      Location
      Clinical Trial Site
      Aurora, Colorado, United States, 80045
      Status
      Recruiting
      Location
      Clinical Trial Site
      Washington D.C., District of Columbia, United States, 20007
      Status
      Recruiting
      Location
      Clinical Trial Site
      Gainesville, Florida, United States, 32610
      Status
      Recruiting
      Location
      Clinical Trial Site
      Atlanta, Georgia, United States, 30322
      Status
      Recruiting
      Location
      Clinical Trial Site
      Chicago, Illinois, United States, 60614
      Status
      Withdrawn
      Location
      Clinical Trial Site
      Boston, Massachusetts, United States, 02115
      Status
      Recruiting
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