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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who experience specified events | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
| Name | Affiliation | Role |
|---|---|---|
| Nuria Saval | Alexion Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40875209 | Derived | 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. | |
| 36152218 |
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| Clinical Trial Site | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| Clinical Trial Site | Recruiting | Gainesville | Florida | 32610 | United States |
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| Clinical Trial Site | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Clinical Trial Site | Withdrawn | Chicago | Illinois | 60614 | United States |
| Clinical Trial Site | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Clinical Trial Site | Recruiting | St Louis | Missouri | 63110 | United States |
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| Clinical Trial Site | Withdrawn | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Trial Site | Active, not recruiting | Columbus | Ohio | 43210 | United States |
| Clinical Trial Site 1 | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Clinical Trial Site 2 | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Clinical Trial Site | Recruiting | Cairns | Queensland | 4870 | Australia |
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| Clinical Trial Site | Recruiting | Herston | Queensland | 4029 | Australia |
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| Clinical Trial Site | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Clinical Trial Site | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Clinical Trial Site | Recruiting | Heidelberg | Victoria | 3084 | Australia |
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| Clinical Trial Site | Recruiting | Parkville | Victoria | 3050 | Australia |
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| Clinical Trial Site | Recruiting | Parkville | Victoria | 3052 | Australia |
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| Clinical Trial Site | Recruiting | Murdoch | Western Australia | 6961 | Australia |
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| Clinical Trial Site | Active, not recruiting | Nedlands | Western Australia | 6109 | Australia |
| Clinical Trial Site | Active, not recruiting | Brussels | 1020 | Belgium |
| Clinical Trial Site | Recruiting | Brussels | 1070 | Belgium |
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| Clinical Trial Site | Recruiting | Brussels | 1090 | Belgium |
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| Clinical Trial Site (Adult) | Recruiting | Edegem | 2650 | Belgium |
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| Clinical Trial Site (Pediatric) | Recruiting | Edegem | 2650 | Belgium |
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| Clinical Trial Site (pediatric) | Recruiting | Ghent | 9000 | Belgium |
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| Clinical Trial Site (Adult) | Recruiting | Leuven | 3000 | Belgium |
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| Clinical Trial Site (pediatric) | Recruiting | Leuven | 3000 | Belgium |
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| Clinical Trial Site (Adult) | Recruiting | Liège | 4000 | Belgium |
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| Clinical Trial Site (pediatric) | Recruiting | Liège | 4000 | Belgium |
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| Clinical Trial Site (adult) | Recruiting | Woluwe-Saint-Lambert | 1200 | Belgium |
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| Clinical Trial Site (Pediatric) | Recruiting | Woluwe-Saint-Lambert | 1200 | Belgium |
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| Clinical Trial Site | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| Clinical Trial Site | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Clinical Trial Site | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| Clinical Trial Site | Recruiting | Québec | Quebec | 44035 | Canada |
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| Clinical Trial Site | Recruiting | Odense | 5000 | Denmark |
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| Clinical Trial Site 1 | Recruiting | Amiens | 80054 | France |
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| Clinical Trial Site 2 | Recruiting | Amiens | 80054 | France |
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| Clinical Trial Site | Recruiting | Angers | 49933 | France |
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| Clinical Trial Site | Recruiting | Bayonne | 64109 | France |
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| Clinical Trial Site | Active, not recruiting | Bordeaux | 33076 | France |
| Clinical Trial Site | Recruiting | Brest | 29609 | France |
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| Clinical Trial Site | Recruiting | Bron | 69677 | France |
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| Clinical Trial Site | Recruiting | Caen | 30001 | France |
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| Clinical Trial Site | Recruiting | Chambéry | 73011 | France |
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| Clinical Trial Site | Recruiting | Clermont-Ferrand | 63000 | France |
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| Clinical Trial Site | Recruiting | Dijon | 21080 | France |
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| Clinical Trial Site | Recruiting | Grenoble | 38043 | France |
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| Clinical Trial Site | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| Clinical Trial Site | Recruiting | Lille | 59037 | France |
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| Clinical Trial Site | Withdrawn | Lille | France |
| Clinical Trial Site | Recruiting | Lyon | France |
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| Clinical Trial Site | Recruiting | Marseille | France |
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| Clinical Trial Site | Recruiting | Montpellier | France |
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| Clinical Trial Site 1 | Recruiting | Nancy | 54500 | France |
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| Clinical Trial Site | Recruiting | Nancy | 54500 | France |
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| Clinical Trial Site | Recruiting | Nantes | 44 093 | France |
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| Clinical Trial Site 1 | Recruiting | Nantes | 44000 | France |
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| Clinical Trial Site | Recruiting | Nice | 51069 | France |
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| Clinical Trial Site 2 | Recruiting | Paris | 75015 | France |
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| Clinical Trial Site 4 | Recruiting | Paris | 75015 | France |
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| Clinical Trial Site 1 | Recruiting | Paris | 75019 | France |
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| Clinical Trial Site 5 | Recruiting | Paris | 75743 | France |
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| Clinical Trial Site 3 | Recruiting | Paris | 75970 | France |
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| Clinical Trial Site | Recruiting | Perpignan | France |
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| Clinical Trial Site | Recruiting | Poitiers | France |
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| Clinical Trial Site | Recruiting | Pontoise | France |
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| Clinical Trial Site | Recruiting | Rennes | 35203 | France |
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| Clinical Trial Site | Recruiting | Rennes | France |
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| Clinical Trial Site 1 | Recruiting | Rouen | France |
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| Clinical Trial Site 2 | Recruiting | Rouen | France |
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| Clinical Trial Site 1 | Recruiting | Strasbourg | France |
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| Clinical Trial Site 2 | Recruiting | Strasbourg | France |
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| Clinical Trial Site | Recruiting | Toulouse | 31059 | France |
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| Clinical Trial Site | Recruiting | Toulouse | 70034 | France |
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| Clinical Trial Site | Recruiting | Tours | France |
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| Clinical Trial Site | Recruiting | Valenciennes | 50479 | France |
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| Clinical Trial Site | Recruiting | Essen | 45147 | Germany |
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| Clinical Trial Site 1 | Recruiting | Hanover | 30625 | Germany |
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| Clinical Trial Site 2 | Recruiting | Hanover | 30625 | Germany |
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| Clinical Trial Site | Recruiting | Heidelberg | 69120 | Germany |
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| Clinical Trial Site | Active, not recruiting | Lübeck | 23538 | Germany |
| Clinical Trial Site | Recruiting | Münster | 48149 | Germany |
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| Clinical Trial Site | Withdrawn | Tübingen | 72076 | Germany |
| Clinical Trial Site | Recruiting | Beersheba | 84101 | Israel |
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| Clinical Trial Site 1 | Recruiting | Bari | 70124 | Italy |
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| Clinical Trial Site 2 | Recruiting | Bari | 70124 | Italy |
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| Clinical Trial Site | Recruiting | Florence | 50134 | Italy |
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| Clinical Trial Site | Recruiting | Genova | 16147 | Italy |
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| Clinical Trial Site 1 | Recruiting | Milan | 20122 | Italy |
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| Clinical Trial Site 2 | Recruiting | Milan | 20122 | Italy |
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| Clinical Trial Site | Recruiting | Milan | 20163 | Italy |
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| Clinical Trial Site | Recruiting | Roma | 00165 | Italy |
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| Clinical Trial Site | Withdrawn | Torino | Italy |
| Clinical Trial Site | Recruiting | Lodz | 92-213 | Poland |
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| Clinical Trial Site | Recruiting | Lodz | 93-338 | Poland |
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| Clinical Trial Site 1 | Completed | Moscow | Russia |
| Clinical Trial Site 2 | Completed | Moscow | Russia |
| Clinical Trial Site | Completed | Saint Petersburg | Russia |
| Clinical Trial Site | Recruiting | Dongan | Chungcheongnam-do | 31151 | South Korea |
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| Clinical Trial Site | Recruiting | Seoul | Dongnam-ro | 05278 | South Korea |
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| Clinical Trial Site | Active, not recruiting | Anyang-si | Gyeonggi-do | 14068 | South Korea |
| Clinical Trial Site | Withdrawn | Goyang-si | Gyeonggi-do | 411-706 | South Korea |
| Clinical Trial Site | Recruiting | Daegu | Hyeonchung-ro | 42415 | South Korea |
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| Clinical Trial Site | Recruiting | Gwangju | Jebong Ro | 61469 | South Korea |
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| Clinical Trial Site | Recruiting | Daegu | 35015 | South Korea |
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| Clinical Trial Site 1 | Active, not recruiting | Gyeonggi-do | 13620 | South Korea |
| Clinical Trial Site 2 | Recruiting | Gyeonggi-do | 46371 | South Korea |
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| Clinical Trial Site | Active, not recruiting | Jeju-do | 63241 | South Korea |
| Clinical Trial Site | Active, not recruiting | Jeollabuk-do | 54907 | South Korea |
| Clinical Trial Site 2 | Recruiting | Seoul | 02841 | South Korea |
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| Clinical Trial Site 3 | Recruiting | Seoul | 03722 | South Korea |
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| Clinical Trial Site 5 | Recruiting | Seoul | 05505 | South Korea |
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| Clinical Trial Site 6 | Recruiting | Seoul | 06351 | South Korea |
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| Clinical Trial Site 7 | Recruiting | Seoul | 07985 | South Korea |
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| Clinical Trial Site 4 | Recruiting | Seoul | 08308 | South Korea |
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| Clinical Trial Site 1 | Recruiting | Seoul | South Korea |
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| Clinical Trial Site 1 | Recruiting | Barcelona | 09-08035 | Spain |
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| Clinical Trial Site 2 | Recruiting | Barcelona | 09-08035 | Spain |
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| Clinical Trial Site | Recruiting | Pamplona | 15-31008 | Spain |
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| Clinical Trial Site | Withdrawn | Seville | 01-41013 | Spain |
| Clinical Trial Site | Terminated | Basel | 4031 | Switzerland |
| Clinical Trial Site | Terminated | Bern | 3010 | Switzerland |
| Clinical Trial Site | Terminated | Surich | 8091 | Switzerland |
| Clinical Trial Site | Recruiting | Kaohsiung City | 81362 | Taiwan |
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| Clinical Trial Site | Recruiting | New Taipei City | 10002 | Taiwan |
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| Clinical Trial Site | Recruiting | Taichung | 40447 | Taiwan |
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| Clinical Trial Site | Recruiting | Taoyuan | 33305 | Taiwan |
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| Clinical Trial Site | Recruiting | Ankara | 06500 | Turkey (Türkiye) |
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| Clinical Trial Site | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
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| Clinical Trial Site | Recruiting | Kayseri | 38039 | Turkey (Türkiye) |
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| Clinical Trial Site | Recruiting | Cardiff | C14 4XW | United Kingdom |
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| Clinical Trial Site | Recruiting | Exeter | EX2 5DW | United Kingdom |
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| Clinical Trial Site | Recruiting | London | NW3 2PF | United Kingdom |
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| Clinical Trial Site | Recruiting | London | W1T 4EU | United Kingdom |
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| Clinical Trial Site | Recruiting | London | WC1N 3JH | United Kingdom |
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| Clinical Trial Site | Recruiting | Manchester | M13 9WL | United Kingdom |
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| Clinical Trial Site | Withdrawn | Newcastle | NE7 7DN | United Kingdom |
| Clinical Trial Site | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| Clinical Trial Site | Recruiting | Wales | SA6 6NL | United Kingdom |
|
| 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. |
| 27871301 | Derived | 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. |
| 26654630 | Derived | 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. |
| 24843058 | Derived | 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. |
| 24360866 | Derived | 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. |
| ID | Term |
|---|---|
| D065766 | Atypical Hemolytic Uremic Syndrome |
| D057049 | Thrombotic Microangiopathies |
| ID | Term |
|---|---|
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
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