Atypical Hemolytic Uremic Syndrome Clinical Trial
— LTFUOfficial title:
An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study
Verified date | February 2017 |
Source | Alexion Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.
Status | Terminated |
Enrollment | 94 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - aHUS patients who participated in any one of the aHUS-eculizumab clinical studies. - aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | North Tce. Adelaide | |
Austria | Universitatsklinik fur Innere Medizin Medizinische Universitat Graz | Graz | |
Austria | Medizinische Universitaet Innsbruck | Innsbruck | |
Belgium | UZ Gent Dienst nefrologie | Gent | |
Belgium | Chu Sart Tilman | Liège | |
Canada | Centre Hospitalier Universitaire (CHU) Sainte-Justine | Montreal | |
Canada | The Hospital for Sick Children | Toronto | |
France | Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse | Bordeaux Cedex | |
France | CHRU de Caen | Caen | |
France | Le Kremlin Bicetre Hospital, Nephrology Unit | Le Kremlin Bicetre | |
France | CHRU de Lille-Hopital A.Calmette | Lille | |
France | Hôpital Edouard Herriot | Lyon | |
France | Hopital de la Timone Enfants, Unité de Néphrologie | Marseille | |
France | CHU Hotel Dieu | Nantes | |
France | Le Centre Hospitalier Universitaire de Nice | Nice | |
France | Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse | Orleans | |
France | Hopital Robert-Debré, Service de Néphrologie Pédiatrique | Paris | |
France | Hopital Tenon | Paris | |
France | Centre Hospitalier Inter-Communal de Cornouaille | Quimper | |
France | CHU-CH Charles Nicolle Pavillon de Pédiatrie | Rouen | |
France | Hôpital de Bois Guillaume CHU de Rouen | Rouen Cedex | |
France | CHU de Saint-Etienne | Saint Priest En Jarez | |
France | Nouvel Hopital Civil | Strasbourg | |
France | CHRU de Tours | Tours | |
Germany | Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten | Aachen | |
Germany | Hannover University Clinic | Hannover | |
Germany | Universitaet Heidelberg | Heidelberg | |
Italy | A.O. Papa Giovanni XXIII | Bergamo | |
Italy | Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | Istituto Giannina Gaslini | Genova | |
Italy | Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico | Milano | |
Italy | Ospedale dei Bambini G. di Cristina | Palermo | |
Netherlands | AMC Medical Research B.V. | Amsterdam | |
Netherlands | Radboud University Nijmegen Medical Centre Nijmegen | Nijmegen | |
Sweden | Nephrology Clinic, Karolinska University Hospital | Stockholm | |
Switzerland | INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie | Bern | |
United Kingdom | Royal Devon & Exeter NHS Foundation Trust | Exeter | |
United Kingdom | Gartnavel General Hospital | Glasgow | |
United Kingdom | The Newcastle upon Tyne Hospitals NHS | Newcastle upon Tyne | |
United Kingdom | City Hospital, Nottingham University Hospitals, NHS Trust | Nottingham | |
United States | Emory Healthcare - Children's Center | Atlanta | Georgia |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Children's Hospital at Montefiore | Bronx | New York |
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
United States | Arthur James Cancer Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Dunwoody Pediatrics & Children's Healthcare of Atlanta | Dunwoody | Georgia |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Hudson Valley Oncology Hematology | Hawthorne | New York |
United States | The Methodist Hospital Research Institute | Houston | Texas |
United States | Weill Cornell Medical College | New York | New York |
United States | Fox Valley Hematology | Osh Kosh | Wisconsin |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Alexion Pharmaceuticals |
United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TMA complication-free survival | Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study. | 5 Years | |
Secondary | Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention | Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events. | 5 Years |
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