Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

Completed · Phase 3

Conditions studied: Hemoglobinuria, Paroxysmal

In brief

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

Key facts

Study ID

NCT00122304

Run by

Alexion Pharmaceuticals, Inc.

People needed

85

Starts

2004-12-01

Expected to finish

2006-11-01

Last updated by the study team

2007-02-21

Who can join

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

You may qualify if…

• PNH > 6 months
• 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

You may not qualify if…

• Platelet count of <30,000/mm3
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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