Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
NCT ID: NCT00122330
Last Updated: 2006-12-04
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
75 participants
INTERVENTIONAL
2004-10-31
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
ECT
DOUBLE
Interventions
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eculizumab
Eligibility Criteria
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Inclusion Criteria
* PNH type III red blood cell (RBC) clone by flow cytometry of \>10%
* Lactate dehydrogenase (LDH) level \> 1.5 x upper limit of normal
* Platelet count \> 100,000/mm3
* Patient taking erythropoietin must be on a stable dose for at least 26 weeks
* Patient taking immunosuppressants must be on a stable dose for at least 26 weeks
* Patient taking corticosteroids must be on a stable dose for at least 4 weeks
* Patient taking coumadin must be at a stable INR for at least 4 weeks
* Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks
* Willing and able to give written informed consent
* Must avoid conception
Exclusion Criteria
* Absolute neutrophil count \<500/ul
* Active bacterial infection
* Hereditary complement deficiency
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days
* Pregnant, breast-feeding, or intending to conceive
* History of meningococcal disease
* History of bone marrow transplantation
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Locations
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City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant
Duarte, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Scripps Cancer Center
San Diego, 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, Dept. of Clinical Research
Weston, Florida, United States
Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology
Indianapolis, Indiana, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
National Heart, Blood, and Lung Institute, National Institutes of Health
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine, Dept. 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 Health System, Division of Cell Therapy, Heme Malignancies Program
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program
Philadelphia, Pennsylvania, United States
Princess Alexandra Hospital, Oncology Haematology Radiation Department
Woolloongabba, Queensland, Australia
Queen Elizabeth Hospital, Dept. of Haematology
Woodville South, South Australia, Australia
Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology
Parkville, Victoria, Australia
The Royal Perth Hosptial, Department of Haematology/Level 2
Perth, Western Australia, Australia
Ucl St. Luc, Hematology Department
Brussels, , Belgium
University of Alberta, Cross Cancer Institute
Edmonton, Alberta, Canada
Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale
Cedex, Paris, France
Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle
Cedex, Paris, France
Universitatsklinikum Essen, Zentrum fur Innere Medizin
Essen, , Germany
Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie
Greifswald, , Germany
Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
Hanover, , Germany
Saarland University Medical School, Internal Medicine 1
Homburg/Saar, , Germany
Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm
Ulm, , Germany
St. James Hospital, Haematology Department
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
Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
Napoli, , Italy
Ospedale San Bortolo, Divisione di Ematologia
Vicenza, , Italy
UMC St. Radboud, Dept. of Hematology
Nijmegen, GA, Netherlands
Lund University Hospital, Department of Internal Medicine, Section of Hematology
Lund, , Sweden
Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology
Umeå, , Sweden
Universitatsklinik Basel, Division of Hematology
Basel, CH, Switzerland
Royal Cornwall Hospital, Haematology Dept.
Truro, Cornwall, United Kingdom
Belfast City Hospital, Dept. of Haematology C Floor
Belfast, , United Kingdom
Leeds General Infirmary, D Floor Brotherton Wing
Leeds, , United Kingdom
St. George's Hospital, Department of Haematology
London, , United Kingdom
Countries
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References
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Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, Roth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43. doi: 10.1056/NEJMoa061648.
Hill A, Rother RP, Wang X, Morris SM Jr, Quinn-Senger K, Kelly R, Richards SJ, Bessler M, Bell L, Hillmen P, Gladwin MT. Effect of eculizumab on haemolysis-associated nitric oxide depletion, dyspnoea, and measures of pulmonary hypertension in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2010 May;149(3):414-25. doi: 10.1111/j.1365-2141.2010.08096.x. Epub 2010 Mar 8.
Other Identifiers
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TRIUMPH
Identifier Type: -
Identifier Source: org_study_id