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Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Hemoglobinuria, Paroxysmal

Thank you

Trial Information

Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acceptable safety (adverse events [AEs], labs, electrocardiograms [ECGs], vital signs)

Authority:

United States: Food and Drug Administration

Study ID:

SHEPHERD

NCT ID:

NCT00122304

Start Date:

December 2004

Completion Date:

November 2006

Related Keywords:

  • Hemoglobinuria, Paroxysmal
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Roswell Park Cancer InstituteBuffalo, New York  14263
Massachusetts General HospitalBoston, Massachusetts  02114-2617
The Cleveland Clinic FoundationCleveland, Ohio  
Indiana University Cancer PavilionIndianapolis, Indiana  46202
Stanford University Medical Center, Division of HematologyStanford, California  94305-5112
Norris Comprehensive Cancer CenterLos Angeles, California  90033
Hartford Hospital, Cancer Clinical Research OfficeHartford, Connecticut  06102
Cleveland Clinic Florida, Dept. of Clinical ResearchWeston, Florida  33331
Johns Hopkins University Medical CenterBaltimore, Maryland  21205
National Heart, Lung, and Blood Institute, National Institutes of HealthBethesda, Maryland  20892
Mayo Clinic, Division of HematologyRochester, Minnesota  55905
Washington University Medical Center, Department of Internal Medicine/Division of HematologySt. Louis, Missouri  63110
Cooper University Hospital, Cooper Cancer InstituteVoorhees, New Jersey  08043
NYU Clinical Cancer CenterNew York, New York  10016
Duke University Medical Center, Division Cell Therapy, Heme Malignancies ProgramDurham, North Carolina  27710
OHSU Center for Hematologic MalignanciesPortland, Oregon  97239
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis ProgramPhiladelphia, Pennsylvania  19104
University of Utah, Hematology-BMT DepartmentSalt Lake City, Utah  84132