Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Completed · Phase 3

Conditions studied: Hemoglobinuria, Paroxysmal

In brief

The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

Key facts

Study ID

NCT00122330

Run by

Alexion Pharmaceuticals, Inc.

People needed

75

Starts

2004-10-01

Expected to finish

2006-01-01

Last updated by the study team

2006-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have required at least 4 transfusions in the past 12 months
• 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

You may not qualify if…

• Mean hemoglobin level prior to transfusion over the previous 12 months is >10.5 gm/dl
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.