Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
NCT ID: NCT00122304
Last Updated: 2007-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
85 participants
INTERVENTIONAL
2004-12-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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eculizumab
Eligibility Criteria
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Inclusion Criteria
* Type III PNH red blood cell (RBC) clone by flow cytometry \>10%
* At least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic PNH
* Lactate dehydrogenase (LDH) \>1.5 x upper limit of normal
* Must avoid conception
* Willing and able to give written informed consent
Exclusion Criteria
* Absolute neutrophil count \<500/ul
* Active bacterial infection
* Hereditary complement deficiency
* History of bone marrow transplantation
* Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days
* Pregnant, breast-feeding, or intending to conceive
* History of meningococcal disease
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Locations
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Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University Medical Center, Division of Hematology
Stanford, California, United States
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States
Cleveland Clinic Florida, Dept. of Clinical Research
Weston, Florida, United States
Indiana University Cancer Pavilion
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, Division of Hematology
Rochester, Minnesota, United States
Washington University Medical Center, Department of Internal Medicine/Division of Hematology
St Louis, Missouri, United States
Cooper University Hospital, Cooper Cancer Institute
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, 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
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
OHSU Center for Hematologic Malignancies
Portland, Oregon, United States
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program
Philadelphia, Pennsylvania, United States
University of Utah, Hematology-BMT Department
Salt Lake City, Utah, United States
Royal North Shore Hospital, Haematology Department
Saint Leonard, 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, Dept. of Haematology/Level 2
Perth, Western Australia, Australia
Royal Melbourne Hospital, Dept. 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 Immungenetik, Abtlg. Transfusionmedizin des Univer. Ulm
Ulm, , Germany
St. James Hospital, Haematology Dept., Cancer Clinical Trial Office
Dublin, , Ireland
Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
Florence, , Italy
Ospedale San Martino, Dept. of Hematology
Genova, , Italy
Ospedale Maggiore di Milano, Divisione di Ematologia
Milan, , Italy
Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
Napoli, , Italy
Ospedale San Bortolo, Divisione di Ematologia
Vicenza, , Italy
UMC St. Radboud, Department of Hematology
Nijmegen, , 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
University Hospital, Dept. of Haematology
Uppsala, , Sweden
Kantonsspital Basel, Abteilung fuer Haematologie
Basel, , Switzerland
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Leeds General Infirmary, D Floor Brotherton Wing
Leeds, , United Kingdom
St. Georges Hospital, Department of Haematology
London, , United Kingdom
Countries
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Other Identifiers
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C04-002
Identifier Type: -
Identifier Source: secondary_id
SHEPHERD
Identifier Type: -
Identifier Source: org_study_id
NCT00133120
Identifier Type: -
Identifier Source: nct_alias
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