Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Last updated: November 13, 2024
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Platelet Disorders

Renal Failure

Treatment

N/A

Clinical Study ID

NCT01522183
M11-001
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients of any age, including minors, who have been diagnosed withaHUS

  • Patients with or without an identified complement pathogenic variant oranti-complement factor antibody

  • Able to give written informed consent. Patient or patient's parent/legal guardianmust be willing and able to given written informed consent and the patient (ifminor) must be willing to give written informed assent [if applicable as determinedby the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].

  • ADAMTS13 > 5%, if performed.

Exclusion

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 guardianunable to give written informed consent. Patient (if minor) unable to give writteninformed assent (if applicable as determined by the central Institutional ReviewBoards/Independent Ethics Committees [IRB/IEC]).

Study Design

Total Participants: 3000
Study Start date:
April 26, 2012
Estimated Completion Date:
January 01, 2031

Study Description

The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.

Connect with a study center

  • Nepean Hospital

    Penrith, New South Wales
    Australia

    Site Not Available

  • Clinical Trial Site 1

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Clinical Trial Site 2

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Cairns, Queensland 4870
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Herston, Queensland 4029
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Murdoch, Western Australia 6961
    Australia

    Active - Recruiting

  • Clinical Trial Site

    Nedlands, Western Australia 6109
    Australia

    Site Not Available

  • Clinical Trial Site

    Brussels, 1090
    Belgium

    Active - Recruiting

  • Clinical Trial Site (Adult)

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Clinical Trial Site (Pediatric)

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Clinical Trial Site (pediatric)

    Gent, 9000
    Belgium

    Active - Recruiting

  • Clinical Trial Site (Adult)

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Clinical Trial Site (pediatric)

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Clinical Trial Site (Adult)

    Liège, 4000
    Belgium

    Active - Recruiting

  • Clinical Trial Site (pediatric)

    Liège, 4000
    Belgium

    Active - Recruiting

  • Clinical Trial Site (Pediatric)

    Woluwe-Saint-Lambert, 1200
    Belgium

    Active - Recruiting

  • Clinical Trial Site (adult)

    Woluwe-Saint-Lambert, 1200
    Belgium

    Active - Recruiting

  • Clinical Trial Site

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montréal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Québec, Quebec 44035
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Odense, 5000
    Denmark

    Active - Recruiting

  • Clinical Trial Site

    Amiens, 80054
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Amiens, 80054
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Amiens, 80054
    France

    Active - Recruiting

  • Clinical Trial Site

    Angers, 49933
    France

    Active - Recruiting

  • Clinical Trial Site

    Bayonne, 64109
    France

    Active - Recruiting

  • Clinical Trial Site

    Bordeaux, 33076
    France

    Site Not Available

  • Clinical Trial Site

    Brest, 29609
    France

    Active - Recruiting

  • Clinical Trial Site

    Bron, 69677
    France

    Active - Recruiting

  • CHRU de Caen Hopital Clemenceau Service de Nephrologie

    Caen,
    France

    Site Not Available

  • Clinical Trial Site

    Caen, 30001
    France

    Active - Recruiting

  • Clinical Trial Site

    Chambéry, 73011
    France

    Active - Recruiting

  • Clinical Trial Site

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Clinical Trial Site

    Dijon, 21080
    France

    Active - Recruiting

  • Clinical Trial Site

    Grenoble, 38043
    France

    Active - Recruiting

  • Clinical Trial Site

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Clinical Trial Site

    Lille, 59037
    France

    Active - Recruiting

  • Clinical Trial Site

    Lyon,
    France

    Active - Recruiting

  • Clinical Trial Site

    Marseille,
    France

    Active - Recruiting

  • Clinical Trial Site

    Montpellier,
    France

    Active - Recruiting

  • Clinical Trial Site

    Nancy, 54500
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Nancy, 54500
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Nancy, 54511
    France

    Active - Recruiting

  • Clinical Trial Site

    Nantes, 44 093
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Nantes, 44000
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Nantes, 44093
    France

    Active - Recruiting

  • Clinical Trial Site

    Nice, 51069
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Paris, 75019
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Paris, 75015
    France

    Active - Recruiting

  • Clinical Trial Site 3

    Paris, 75970
    France

    Active - Recruiting

  • Clinical Trial Site 4

    Paris, 75015
    France

    Active - Recruiting

  • Clinical Trial Site 5

    Paris, 75743
    France

    Active - Recruiting

  • Clinical Trial Site

    Perpignan,
    France

    Active - Recruiting

  • Clinical Trial Site

    Poitiers,
    France

    Active - Recruiting

  • Clinical Trial Site

    Pontoise,
    France

    Active - Recruiting

  • Clinical Trial Site

    Rennes, 35203
    France

    Active - Recruiting

  • Clinical Trial Site

    Rouen,
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Rouen,
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Rouen,
    France

    Active - Recruiting

  • Clinical Trial Site

    Strasbourg,
    France

    Active - Recruiting

  • Clinical Trial Site 1

    Strasbourg,
    France

    Active - Recruiting

  • Clinical Trial Site 2

    Strasbourg,
    France

    Active - Recruiting

  • Clinical Trial Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Clinical Trial Site

    Tours,
    France

    Active - Recruiting

  • Clinical Trial Site

    Valenciennes, 50479
    France

    Active - Recruiting

  • Clinical Trial Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Clinical Trial Site 1

    Hannover, 30625
    Germany

    Active - Recruiting

  • Clinical Trial Site 2

    Hannover, 30625
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Luebeck, 23538
    Germany

    Site Not Available

  • Clinical Trial Site

    Münster, 48149
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Clinical Trial Site

    Be'er Sheva, 84101
    Israel

    Active - Recruiting

  • Clinical Trial Site 1

    Bari, 70124
    Italy

    Active - Recruiting

  • Clinical Trial Site 2

    Bari, 70124
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Genova, 16147
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Milano, 20163
    Italy

    Active - Recruiting

  • Clinical Trial Site 1

    Milano, 20122
    Italy

    Active - Recruiting

  • Clinical Trial Site 2

    Milano, 20122
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Roma, 00165
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Torino,
    Italy

    Site Not Available

  • Clinical Trial Site

    Dongan, Chungcheongnam-do 31151
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Seoul, Dongnam-ro 05278
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Anyang-si, Gyeonggi-do 14068
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Goyang-si, Gyeonggi-do 411-706
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Daegu, Hyeonchung-ro 42415
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Gwangju, Jebong Ro 61469
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Changwon, 52828
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site 1

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site 2

    Gyeonggi-do, 46371
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Gyeongsang,
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Jeju-do, 63241
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Jeollabuk-do, 54907
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site 1

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 2

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 3

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 4

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 5

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 6

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site 7

    Seoul, 07985
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Łódź, 92-213
    Poland

    Active - Recruiting

  • Sverdlovsk Regional Clinical Hospital No. 1

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital No. 1

    Khabarovsk,
    Russian Federation

    Site Not Available

  • Clinical Trial Site 1

    Moscow,
    Russian Federation

    Completed

  • Clinical Trial Site 2

    Moscow,
    Russian Federation

    Completed

  • Clinical Trial Site

    Saint Petersburg,
    Russian Federation

    Completed

  • Clinical Trial Site

    Barcelona, 09-08035
    Spain

    Active - Recruiting

  • Clinical Trial Site 1

    Barcelona, 09-08035
    Spain

    Active - Recruiting

  • Clinical Trial Site 2

    Barcelona, 09-08035
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Pamplona, 15-31008
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Sevilla, 01-41013
    Spain

    Site Not Available

  • Clinical Trial Site

    Kaohsiung, 81362
    Taiwan

    Active - Recruiting

  • Clinical Trial Site

    New Taipei City, 10002
    Taiwan

    Active - Recruiting

  • Clinical Trial Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Clinical Trial Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Clinical Trial Site

    Ankara, 06500
    Turkey

    Active - Recruiting

  • Clinical Trial Site

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Clinical Trial Site

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Clinical Trial Site

    Cardiff, C14 4XW
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Exeter, EX2 5DW
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    London, W1T 4EU
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Wales, SA6 6NL
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Clinical Trial Site

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Clinical Trial Site

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Clinical Trial Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Clinical Trial Site

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Clinical Trial Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • INC Research, Inc. via Locations in 22 Countries Globally

    Raleigh, North Carolina
    United States

    Site Not Available

  • Syneos Health

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Clinical Trial Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Clinical Trial Site

    Columbus, Ohio 43210
    United States

    Site Not Available

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