Status:
COMPLETED
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
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 of eculizumab in patients with transfusion-dependent hemolytic PNH
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00122304
Start Date
December 1 2004
End Date
November 1 2006
Last Update
February 21 2007
Active Locations (48)
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1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305
3
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States, 06102
4
Cleveland Clinic Florida, Dept. of Clinical Research
Weston, Florida, United States, 33331