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NCT01522183Recruiting

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Alexion Pharmaceuticals, Inc.

Start Date

3/18/2013

Completion Date

1/1/2031

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: No minimum to No maximum

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 \[IRB/IEC\]).

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Conditions

Atypical Hemolytic-Uremic Syndrome

Locations

Clinical Trial Site

Aurora, Colorado 80045

United States

Clinical Trial Site

Washington D.C., District of Columbia 20007

United States

Clinical Trial Site

Gainesville, Florida 32610

United States

Clinical Trial Site

Atlanta, Georgia 30322

United States

Clinical Trial Site

Chicago, Illinois 60614

United States

Clinical Trial Site

Boston, Massachusetts 02115

United States

Clinical Trial Site

St Louis, Missouri 63110

United States

Clinical Trial Site

Winston-Salem, North Carolina 27103

United States

Clinical Trial Site

Columbus, Ohio 43210

United States

Clinical Trial Site 1

Westmead, New South Wales 2145

Australia

Clinical Trial Site 2

Westmead, New South Wales 2145

Australia

Clinical Trial Site

Cairns, Queensland 4870

Australia

Clinical Trial Site

Herston, Queensland 4029

Australia

Clinical Trial Site

Woolloongabba, Queensland 4102

Australia

Clinical Trial Site

Adelaide, South Australia 5000

Australia

Clinical Trial Site

Heidelberg, Victoria 3084

Australia

Clinical Trial Site

Parkville, Victoria 3050

Australia

Clinical Trial Site

Parkville, Victoria 3052

Australia

Clinical Trial Site

Murdoch, Western Australia 6961

Australia

Clinical Trial Site

Nedlands, Western Australia 6109

Australia

Clinical Trial Site

Brussels, 1020

Belgium

Clinical Trial Site

Brussels, 1070

Belgium

Clinical Trial Site

Brussels, 1090

Belgium

Clinical Trial Site (Adult)

Edegem, 2650

Belgium

Clinical Trial Site (Pediatric)

Edegem, 2650

Belgium

Clinical Trial Site (pediatric)

Ghent, 9000

Belgium

Clinical Trial Site (Adult)

Leuven, 3000

Belgium

Clinical Trial Site (pediatric)

Leuven, 3000

Belgium

Clinical Trial Site (Adult)

Liège, 4000

Belgium

Clinical Trial Site (pediatric)

Liège, 4000

Belgium

Clinical Trial Site (adult)

Woluwe-Saint-Lambert, 1200

Belgium

Clinical Trial Site (Pediatric)

Woluwe-Saint-Lambert, 1200

Belgium

Clinical Trial Site

London, Ontario N6A 5W9

Canada

Clinical Trial Site

Toronto, Ontario M5G 1X8

Canada

Clinical Trial Site

Montreal, Quebec H3T 1C5

Canada

Clinical Trial Site

Québec, Quebec 44035

Canada

Clinical Trial Site

Odense, 5000

Denmark

Clinical Trial Site 1

Amiens, 80054

France

Clinical Trial Site 2

Amiens, 80054

France

Clinical Trial Site

Angers, 49933

France

Clinical Trial Site

Bayonne, 64109

France

Clinical Trial Site

Bordeaux, 33076

France

Clinical Trial Site

Brest, 29609

France

Clinical Trial Site

Bron, 69677

France

Clinical Trial Site

Caen, 30001

France

Clinical Trial Site

Chambéry, 73011

France

Clinical Trial Site

Clermont-Ferrand, 63000

France

Clinical Trial Site

Dijon, 21080

France

Clinical Trial Site

Grenoble, 38043

France

Clinical Trial Site

Le Kremlin-Bicêtre, 94270

France

Clinical Trial Site

Lille, 59037

France

Clinical Trial Site

Lille,

France

Clinical Trial Site

Lyon,

France

Clinical Trial Site

Marseille,

France

Clinical Trial Site

Montpellier,

France

Clinical Trial Site 1

Nancy, 54500

France

Clinical Trial Site

Nancy, 54500

France

Clinical Trial Site

Nantes, 44 093

France

Clinical Trial Site 1

Nantes, 44000

France

Clinical Trial Site

Nice, 51069

France

Clinical Trial Site 2

Paris, 75015

France

Clinical Trial Site 4

Paris, 75015

France

Clinical Trial Site 1

Paris, 75019

France

Clinical Trial Site 5

Paris, 75743

France

Clinical Trial Site 3

Paris, 75970

France

Clinical Trial Site

Perpignan,

France

Clinical Trial Site

Poitiers,

France

Clinical Trial Site

Pontoise,

France

Clinical Trial Site

Rennes, 35203

France

Clinical Trial Site

Rennes,

France

Clinical Trial Site 1

Rouen,

France

Clinical Trial Site 2

Rouen,

France

Clinical Trial Site 1

Strasbourg,

France

Clinical Trial Site 2

Strasbourg,

France

Clinical Trial Site

Toulouse, 31059

France

Clinical Trial Site

Toulouse, 70034

France

Clinical Trial Site

Tours,

France

Clinical Trial Site

Valenciennes, 50479

France

Clinical Trial Site

Essen, 45147

Germany

Clinical Trial Site 1

Hanover, 30625

Germany

Clinical Trial Site 2

Hanover, 30625

Germany

Clinical Trial Site

Heidelberg, 69120

Germany

Clinical Trial Site

Lübeck, 23538

Germany

Clinical Trial Site

Münster, 48149

Germany

Clinical Trial Site

Tübingen, 72076

Germany

Clinical Trial Site

Beersheba, 84101

Israel

Clinical Trial Site 1

Bari, 70124

Italy

Clinical Trial Site 2

Bari, 70124

Italy

Clinical Trial Site

Florence, 50134

Italy

Clinical Trial Site

Genova, 16147

Italy

Clinical Trial Site 1

Milan, 20122

Italy

Clinical Trial Site 2

Milan, 20122

Italy

Clinical Trial Site

Milan, 20163

Italy

Clinical Trial Site

Roma, 00165

Italy

Clinical Trial Site

Torino,

Italy

Clinical Trial Site

Lodz, 92-213

Poland

Clinical Trial Site

Lodz, 93-338

Poland

Clinical Trial Site 1

Moscow,

Russia

Clinical Trial Site 2

Moscow,

Russia

Clinical Trial Site

Saint Petersburg,

Russia

Clinical Trial Site

Dongan, Chungcheongnam-do 31151

South Korea

Clinical Trial Site

Seoul, Dongnam-ro 05278

South Korea

Clinical Trial Site

Anyang-si, Gyeonggi-do 14068

South Korea

Clinical Trial Site

Goyang-si, Gyeonggi-do 411-706

South Korea

Clinical Trial Site

Daegu, Hyeonchung-ro 42415

South Korea

Clinical Trial Site

Gwangju, Jebong Ro 61469

South Korea

Clinical Trial Site

Daegu, 35015

South Korea

Clinical Trial Site 1

Gyeonggi-do, 13620

South Korea

Clinical Trial Site 2

Gyeonggi-do, 46371

South Korea

Clinical Trial Site

Jeju-do, 63241

South Korea

Clinical Trial Site

Jeollabuk-do, 54907

South Korea

Clinical Trial Site 2

Seoul, 02841

South Korea

Clinical Trial Site 3

Seoul, 03722

South Korea

Clinical Trial Site 5

Seoul, 05505

South Korea

Clinical Trial Site 6

Seoul, 06351

South Korea

Clinical Trial Site 7

Seoul, 07985

South Korea

Clinical Trial Site 4

Seoul, 08308

South Korea

Clinical Trial Site 1

Seoul,

South Korea

Clinical Trial Site 1

Barcelona, 09-08035

Spain

Clinical Trial Site 2

Barcelona, 09-08035

Spain

Clinical Trial Site

Pamplona, 15-31008

Spain

Clinical Trial Site

Seville, 01-41013

Spain

Clinical Trial Site

Basel, 4031

Switzerland

Clinical Trial Site

Bern, 3010

Switzerland

Clinical Trial Site

Surich, 8091

Switzerland

Clinical Trial Site

Kaohsiung City, 81362

Taiwan

Clinical Trial Site

New Taipei City, 10002

Taiwan

Clinical Trial Site

Taichung, 40447

Taiwan

Clinical Trial Site

Taoyuan, 33305

Taiwan

Clinical Trial Site

Ankara, 06500

Turkey (Türkiye)

Clinical Trial Site

Istanbul, 34093

Turkey (Türkiye)

Clinical Trial Site

Kayseri, 38039

Turkey (Türkiye)

Clinical Trial Site

Cardiff, C14 4XW

United Kingdom

Clinical Trial Site

Exeter, EX2 5DW

United Kingdom

Clinical Trial Site

London, NW3 2PF

United Kingdom

Clinical Trial Site

London, W1T 4EU

United Kingdom

Clinical Trial Site

London, WC1N 3JH

United Kingdom

Clinical Trial Site

Manchester, M13 9WL

United Kingdom

Clinical Trial Site

Newcastle, NE7 7DN

United Kingdom

Clinical Trial Site

Southampton, SO16 6YD

United Kingdom

Clinical Trial Site

Wales, SA6 6NL

United Kingdom