NCT00122317
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsored by Alexion Pharmaceuticals, Inc.
The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.
Inclusion Criteria: * Patients who have fully completed the TRIUMPH, SHEPHERD, or X03-001 studies * TRIUMPH patients who have discontinued receiving investigational drug prior to the last visit of the study due to lack of efficacy or exacerbation of symptoms of PNH and have completed all monthly safety and efficacy procedures * Patient must be willing and able to give written informed consent * Patient must avoid conception during the trial Exclusion Criteria: * Patients who have terminated early from the SHEPHERD or X03-001 studies * Patients who have terminated early from the TRIUMPH study due to an adverse event * Female who is pregnant, breast feeding, or intending to conceive during the course of the study * Any condition that could increase the patient's risk by participating in the study or could confound the outcome of the study
Stanford University Medical Center, Division of Hematology
Stanford, California, United States
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States
Cleveland Clinic Florida, Department of Clinical Research
Weston, Florida, United States
Indianapolis University Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
National Heart, Lung, and Blood Institute, National Institutes of Health
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic, Divison of Hematology
Rochester, Minnesota, United States
Washington University, Department of Internal Medicine/Division of Hematology
St Louis, Missouri, United States
NYU Clinical Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program
Philadelphia, Pennsylvania, United States
Royal North Shore Hospital, Haematology Department
Saint Leonards, New South Wales, Australia
Princess Alexandra Hospital, Oncology Haematology Radiation Department
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital, Haematology/Oncology Department
Woodville South, South Australia, Australia
The Royal Perth Hospital, Department of Haematology/Level 2
Perth, Western Australia, Australia
Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology
Parkville, Australia
Ucl St. Luc, Hematology Department
Brussels, Belgium
University of Alberta, Cross Cancer Institute
Edmonton, Alberta, Canada
London Regional Cancer Centre, Clinical Research Unit Room C3080
London, Ontario, Canada
Hopital Saint Louis, Centre d'investigation Clinique
Paris, Cedex, France
Universitatsklinikum Essen, Zentrum fur Innere Medizin
Essen, Germany
Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
Hanover, Germany
Universitatskliniken des Saarlandes, Innere Medizin 1
Homburg/Saar, Germany
Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm
Ulm, Germany
St. James's Hospital, Cancer Clinical Trial Office
Dublin, Ireland
Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
Florence, Italy
Ospedale San Martino, Department of Hematology
Genova, Italy
Ospedale Maggiore di Milano, Divisione di Ematologia
Milan, Italy
Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
Naples, Italy
Ospedale San Bortolo, Divisione di Ematologia
Vicenza, Italy
UMC St. Radboud, Department of Hematology
Nijmegen, GA, Netherlands
Hospital Clinic i Provincial, Servicio de Hematologia
Barcelona, Spain
Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia
Barcelona, Spain
Hospital De La Paz, Servicio de Hematologia
Madrid, Spain
Stockholm South Hospital, Division of Hematology
Stockholm, Sweden
Leeds General Infirmary, D Floor Brotherton Wing
Leeds, United Kingdom
St. George's Hospital, Department of Haematology
London, United Kingdom
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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