Status:
COMPLETED
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hemoglobinuria, Paroxysmal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00122330
Start Date
October 1 2004
End Date
January 1 2006
Last Update
December 4 2006
Active Locations (43)
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1
City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant
Duarte, California, United States, 91010-3000
2
University of California at Los Angeles
Los Angeles, California, United States, 90024
3
Scripps Cancer Center
San Diego, California, United States, 92121
4
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305-5821