Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
September 15, 2025 updated by: Alexion Pharmaceuticals, Inc.
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexion Pharmaceuticals, Inc. (Sponsor)
- Phone Number: 1-855-752-2356
- Email: clinicaltrials@alexion.com
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Clinical Trial Site 1
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Contact:
- Durkan
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Clinical Trial Site 2
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Contact:
- Wong
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Queensland
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Cairns, Queensland, Australia, 4870
- Recruiting
- Clinical Trial Site
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Contact:
- Mantha
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Herston, Queensland, Australia, 4029
- Recruiting
- Clinical Trial Site
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Contact:
- Chandler
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Clinical Trial Site
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Contact:
- Isbel
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South Australia
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Adelaide, South Australia, Australia, 5000
- Recruiting
- Clinical Trial Site
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Contact:
- Carroll
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- Clinical Trial Site
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Contact:
- Mount
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Parkville, Victoria, Australia, 3050
- Recruiting
- Clinical Trial Site
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Contact:
- Hughes
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Parkville, Victoria, Australia, 3052
- Recruiting
- Clinical Trial Site
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Contact:
- Kausman
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Western Australia
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Murdoch, Western Australia, Australia, 6961
- Recruiting
- Clinical Trial Site
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Contact:
- Abraham
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Nedlands, Western Australia, Australia, 6109
- Active, not recruiting
- Clinical Trial Site
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-
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Brussels, Belgium, 1070
- Recruiting
- Clinical Trial Site
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Contact:
- Broeders
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Brussels, Belgium, 1090
- Recruiting
- Clinical Trial Site
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Contact:
- Pipeleers
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Brussels, Belgium, 1020
- Active, not recruiting
- Clinical Trial Site
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Edegem, Belgium, 2650
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Massart
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Edegem, Belgium, 2650
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Van Hoeck
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Ghent, Belgium, 9000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Snauwaert
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Leuven, Belgium, 3000
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Claes
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Leuven, Belgium, 3000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Bockenhauer
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Liège, Belgium, 4000
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Weekers
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Liège, Belgium, 4000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Collard
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Woluwe-Saint-Lambert, Belgium, 1200
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Goffin
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Woluwe-Saint-Lambert, Belgium, 1200
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Godefroid
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Ontario
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London, Ontario, Canada, N6A 5W9
- Recruiting
- Clinical Trial Site
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Contact:
- Huang
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- Clinical Trial Site
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Contact:
- Licht
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- Clinical Trial Site
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Contact:
- Lapeyraque
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Québec, Quebec, Canada, 44035
- Recruiting
- Clinical Trial Site
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Contact:
- Philibert
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Odense, Denmark, 5000
- Recruiting
- Clinical Trial Site
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Contact:
- Dieperink
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Amiens, France, 80054
- Recruiting
- Clinical Trial Site 1
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Contact:
- Djeddi
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Amiens, France, 80054
- Recruiting
- Clinical Trial Site 2
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Contact:
- Choukroun
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Angers, France, 49933
- Recruiting
- Clinical Trial Site
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Contact:
- Augusto
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Bayonne, France, 64109
- Recruiting
- Clinical Trial Site
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Contact:
- Lacraz
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Bordeaux, France, 33076
- Active, not recruiting
- Clinical Trial Site
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Brest, France, 29609
- Recruiting
- Clinical Trial Site
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Contact:
- LeMeur
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Bron, France, 69677
- Recruiting
- Clinical Trial Site
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Contact:
- Sellier-LeClerc
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Caen, France, 30001
- Recruiting
- Clinical Trial Site
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Contact:
- Chatelet-Pouliquen
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Chambéry, France, 73011
- Recruiting
- Clinical Trial Site
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Contact:
- Bally
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Clermont-Ferrand, France, 63000
- Recruiting
- Clinical Trial Site
-
Contact:
- Heng
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Dijon, France, 21080
- Recruiting
- Clinical Trial Site
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Contact:
- Legendre
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Grenoble, France, 38043
- Recruiting
- Clinical Trial Site
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Contact:
- Carron
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Le Kremlin-Bicêtre, France, 94270
- Recruiting
- Clinical Trial Site
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Contact:
- Snanoudj
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Lille, France, 59037
- Recruiting
- Clinical Trial Site
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Contact:
- Provot
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Lille, France
- Withdrawn
- Clinical Trial Site
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Lyon, France
- Recruiting
- Clinical Trial Site
-
Contact:
- Jolivot
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Marseille, France
- Recruiting
- Clinical Trial Site
-
Contact:
- Rousset-Rouviere
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Montpellier, France
- Recruiting
- Clinical Trial Site
-
Contact:
- Fila
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Nancy, France, 54500
- Recruiting
- Clinical Trial Site 1
-
Contact:
- Frimat
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Nancy, France, 54500
- Recruiting
- Clinical Trial Site
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Contact:
- Vrillon
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Nantes, France, 44 093
- Recruiting
- Clinical Trial Site
-
Contact:
- Roussey
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Nantes, France, 44000
- Recruiting
- Clinical Trial Site 1
-
Contact:
- Ville
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Nice, France, 51069
- Recruiting
- Clinical Trial Site
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Contact:
- Seitz-Polski
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Paris, France, 75015
- Recruiting
- Clinical Trial Site 2
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Contact:
- Legendre
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Paris, France, 75015
- Recruiting
- Clinical Trial Site 4
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Contact:
- Thervet
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Paris, France, 75743
- Recruiting
- Clinical Trial Site 5
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Contact:
- Boyer
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Paris, France, 75970
- Recruiting
- Clinical Trial Site 3
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Contact:
- Mesnard
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Paris, France, 75019
- Recruiting
- Clinical Trial Site 1
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Contact:
- Hogan
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Perpignan, France
- Recruiting
- Clinical Trial Site
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Contact:
- Vela
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Poitiers, France
- Recruiting
- Clinical Trial Site
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Contact:
- Bridoux
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Pontoise, France
- Recruiting
- Clinical Trial Site
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Contact:
- Devaud
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Rennes, France, 35203
- Recruiting
- Clinical Trial Site
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Contact:
- Taque
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Rennes, France
- Recruiting
- Clinical Trial Site
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Contact:
- Martins
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Rouen, France
- Recruiting
- Clinical Trial Site 1
-
Contact:
- Lebourg
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Rouen, France
- Recruiting
- Clinical Trial Site 2
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Contact:
- Louillet
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Strasbourg, France
- Recruiting
- Clinical Trial Site 1
-
Contact:
- Moulin
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Strasbourg, France
- Recruiting
- Clinical Trial Site 2
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Contact:
- Krummel
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Toulouse, France, 31059
- Recruiting
- Clinical Trial Site
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Contact:
- Kamar
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Toulouse, France, 70034
- Recruiting
- Clinical Trial Site
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Contact:
- Decramer
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Tours, France
- Recruiting
- Clinical Trial Site
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Contact:
- Halimi
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Valenciennes, France, 50479
- Recruiting
- Clinical Trial Site
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Contact:
- Ulrich
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Essen, Germany, 45147
- Recruiting
- Clinical Trial Site
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Contact:
- Gackler
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Hanover, Germany, 30625
- Recruiting
- Clinical Trial Site 1
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Contact:
- Schmidt-Ott
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Hanover, Germany, 30625
- Recruiting
- Clinical Trial Site 2
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Contact:
- Kanzelmeyer
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Heidelberg, Germany, 69120
- Recruiting
- Clinical Trial Site
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Contact:
- Wuehl
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Lübeck, Germany, 23538
- Active, not recruiting
- Clinical Trial Site
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Münster, Germany, 48149
- Recruiting
- Clinical Trial Site
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Contact:
- Konrad
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Tübingen, Germany, 72076
- Withdrawn
- Clinical Trial Site
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Beersheba, Israel, 84101
- Recruiting
- Clinical Trial Site
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Contact:
- Schreiber
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Bari, Italy, 70124
- Recruiting
- Clinical Trial Site 1
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Contact:
- Giordano
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Bari, Italy, 70124
- Recruiting
- Clinical Trial Site 2
-
Contact:
- Gesualdo
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Florence, Italy, 50134
- Recruiting
- Clinical Trial Site
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Contact:
- Cirami
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Genova, Italy, 16147
- Recruiting
- Clinical Trial Site
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Contact:
- Magnasco
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Milan, Italy, 20122
- Recruiting
- Clinical Trial Site 1
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Contact:
- Ardissino
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Milan, Italy, 20122
- Recruiting
- Clinical Trial Site 2
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Contact:
- Verdesca
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Milan, Italy, 20163
- Recruiting
- Clinical Trial Site
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Contact:
- Ravera
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Roma, Italy, 00165
- Recruiting
- Clinical Trial Site
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Contact:
- Vivarelli
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Torino, Italy
- Withdrawn
- Clinical Trial Site
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Lodz, Poland, 92-213
- Recruiting
- Clinical Trial Site
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Contact:
- Nowicki
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Lodz, Poland, 93-338
- Recruiting
- Clinical Trial Site
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Contact:
- Pawlak-Bratkowska
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Moscow, Russia
- Completed
- Clinical Trial Site 1
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Moscow, Russia
- Completed
- Clinical Trial Site 2
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Saint Petersburg, Russia
- Completed
- Clinical Trial Site
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Daegu, South Korea, 35015
- Recruiting
- Clinical Trial Site
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Contact:
- Kim
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Gyeonggi-do, South Korea, 13620
- Active, not recruiting
- Clinical Trial Site 1
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Gyeonggi-do, South Korea, 46371
- Recruiting
- Clinical Trial Site 2
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Contact:
- Young Chong
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Jeju-do, South Korea, 63241
- Active, not recruiting
- Clinical Trial Site
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Jeollabuk-do, South Korea, 54907
- Active, not recruiting
- Clinical Trial Site
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Seoul, South Korea, 02841
- Recruiting
- Clinical Trial Site 2
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Contact:
- Kim
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Seoul, South Korea, 03722
- Recruiting
- Clinical Trial Site 3
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Contact:
- Kim
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Seoul, South Korea, 05505
- Recruiting
- Clinical Trial Site 5
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Contact:
- Hoon Lee
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Seoul, South Korea, 06351
- Recruiting
- Clinical Trial Site 6
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Contact:
- Jang
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Seoul, South Korea, 07985
- Recruiting
- Clinical Trial Site 7
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Contact:
- Mun
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Seoul, South Korea, 08308
- Recruiting
- Clinical Trial Site 4
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Contact:
- Joo Kwon
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Seoul, South Korea
- Recruiting
- Clinical Trial Site 1
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Contact:
- Gyung Kang
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Chungcheongnam-do
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Dongan, Chungcheongnam-do, South Korea, 31151
- Recruiting
- Clinical Trial Site
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Contact:
- Gil
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Dongnam-ro
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Seoul, Dongnam-ro, South Korea, 05278
- Recruiting
- Clinical Trial Site
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Contact:
- Jung
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, South Korea, 14068
- Active, not recruiting
- Clinical Trial Site
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Goyang-si, Gyeonggi-do, South Korea, 411-706
- Withdrawn
- Clinical Trial Site
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Hyeonchung-ro
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Daegu, Hyeonchung-ro, South Korea, 42415
- Recruiting
- Clinical Trial Site
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Contact:
- Do
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Jebong Ro
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Gwangju, Jebong Ro, South Korea, 61469
- Recruiting
- Clinical Trial Site
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Contact:
- Bae
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Barcelona, Spain, 09-08035
- Recruiting
- Clinical Trial Site 1
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Contact:
- Ariceta
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Barcelona, Spain, 09-08035
- Recruiting
- Clinical Trial Site 2
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Contact:
- Ramos
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Pamplona, Spain, 15-31008
- Recruiting
- Clinical Trial Site
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Contact:
- Manrique
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Seville, Spain, 01-41013
- Withdrawn
- Clinical Trial Site
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Basel, Switzerland, 4031
- Terminated
- Clinical Trial Site
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Bern, Switzerland, 3010
- Terminated
- Clinical Trial Site
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Surich, Switzerland, 8091
- Terminated
- Clinical Trial Site
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Kaohsiung City, Taiwan, 81362
- Recruiting
- Clinical Trial Site
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Contact:
- Chiou
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New Taipei City, Taiwan, 10002
- Recruiting
- Clinical Trial Site
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Contact:
- Tsai
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Taichung, Taiwan, 40447
- Recruiting
- Clinical Trial Site
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Contact:
- Huang
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Taoyuan District, Taiwan, 33305
- Recruiting
- Clinical Trial Site
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Contact:
- Tseng
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-
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Ankara, Turkey (Türkiye), 06500
- Recruiting
- Clinical Trial Site
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Contact:
- Derici
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Istanbul, Turkey (Türkiye), 34093
- Recruiting
- Clinical Trial Site
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Contact:
- Yildiz
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Kayseri, Turkey (Türkiye), 38039
- Recruiting
- Clinical Trial Site
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Contact:
- Tokgoz
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Cardiff, United Kingdom, C14 4XW
- Recruiting
- Clinical Trial Site
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Contact:
- Griffin
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Exeter, United Kingdom, EX2 5DW
- Recruiting
- Clinical Trial Site
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Contact:
- Bingham
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London, United Kingdom, WC1N 3JH
- Recruiting
- Clinical Trial Site
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Contact:
- Marks
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London, United Kingdom, NW3 2PF
- Recruiting
- Clinical Trial Site
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Contact:
- Gale
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London, United Kingdom, W1T 4EU
- Recruiting
- Clinical Trial Site
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Contact:
- Scully
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Manchester, United Kingdom, M13 9WL
- Recruiting
- Clinical Trial Site
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Contact:
- Shenoy
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Newcastle, United Kingdom, NE7 7DN
- Withdrawn
- Clinical Trial Site
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Southampton, United Kingdom, SO16 6YD
- Recruiting
- Clinical Trial Site
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Contact:
- Gilbert
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Wales, United Kingdom, SA6 6NL
- Recruiting
- Clinical Trial Site
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Contact:
- Mikhail
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Clinical Trial Site
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Contact:
- Dixon
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
- Recruiting
- Clinical Trial Site
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Contact:
- Broome
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Florida
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Gainesville, Florida, United States, 32610
- Recruiting
- Clinical Trial Site
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Contact:
- Segal
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Clinical Trial Site
-
Contact:
- Greenbaum
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Illinois
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Chicago, Illinois, United States, 60614
- Withdrawn
- Clinical Trial Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Clinical Trial Site
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Contact:
- Alenizi
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Missouri
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St Louis, Missouri, United States, 63110
- Recruiting
- Clinical Trial Site
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Contact:
- Majerus
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Withdrawn
- Clinical Trial Site
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Ohio
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Columbus, Ohio, United States, 43210
- Active, not recruiting
- Clinical Trial Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male or female patients of any age, including minors, who have been diagnosed with aHUS; clinical diagnosis of aHUS, patients with or without an identified complement regulatory factor genetic abnormality or anti-complement factor antibody, ADAMTS13 > 5% (if performed)
Description
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]).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who experience specified events
Time Frame: 10 years
|
To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
|
10 years
|
|
Time to first and subsequent occurrence of specified events.
Time Frame: 5 years
|
To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab or ravulizumab treatment or other disease management approaches
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nuria Saval, Alexion Pharmaceuticals, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. doi: 10.1186/s13023-016-0537-5.
- Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Fremeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1.
- Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19.
- Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21. No abstract available.
- Halimi JM, Al-Dakkak I, Anokhina K, Ardissino G, Licht C, Lim WH, Massart A, Schaefer F, Walle JV, Rondeau E. Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry. J Nephrol. 2023 Apr;36(3):817-828. doi: 10.1007/s40620-022-01465-z. Epub 2022 Sep 24.
- Gaeckler A, Al-Dakkak I, Saval N, Dieperink HH, Eygenraam M, Greenbaum LA, Isbel N, Walle JV. Effectiveness and Safety of Switching to Ravulizumab From Eculizumab in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome: A Global aHUS Registry Analysis. Clin Transplant. 2025 Sep;39(9):e70278. doi: 10.1111/ctr.70278.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2013
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
January 1, 2031
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimated)
January 31, 2012
Study Record Updates
Last Update Posted (Estimated)
September 16, 2025
Last Update Submitted That Met QC Criteria
September 15, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Cytopenia
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Hematologic Diseases
- Anemia, Hemolytic
- Anemia
- Blood Platelet Disorders
- Thrombocytopenia
- Uremia
- Hemic and Lymphatic Diseases
- Hemolytic-Uremic Syndrome
- Thrombotic Microangiopathies
- Atypical Hemolytic Uremic Syndrome
Other Study ID Numbers
- M11-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atypical Hemolytic-Uremic Syndrome
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AlexionCompletedAtypical Hemolytic-Uremic SyndromeUnited Kingdom, United States, France, Italy, Germany, Spain, Belgium
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Alexion PharmaceuticalsCompletedAtypical Hemolytic-Uremic SyndromeUnited Kingdom, Belgium, United States, Germany, Italy, France, Netherlands, Australia, Canada
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Alexion PharmaceuticalsCompletedAtypical Hemolytic Uremic Syndrome (aHUS)Japan
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Alexion PharmaceuticalsCompletedATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)Japan
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University Hospital, GhentCompletedAtypical Hemolytic Uraemic SyndromeBelgium
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-
Alexion Pharmaceuticals, Inc.CompletedAtypical Hemolytic Uremic Syndrome (aHUS)United States, France, Spain, Taiwan, United Kingdom, Australia, Belgium, Germany, Italy, Japan, Korea, Republic of, Russian Federation, Austria, Canada
-
AlexionCompletedAtypical Hemolytic Uremic Syndrome (aHUS)United States, France, Germany, Spain, Switzerland, Netherlands, Canada, Austria
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Alexion Pharmaceuticals, Inc.CompletedAtypical Hemolytic Uremic Syndrome (aHUS)Italy, United States, Korea, Republic of, Spain, Germany, Belgium, United Kingdom