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

Study Identifier:
SHEPHERD
ClinicalTrials.gov Identifier:
NCT00122304
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Hemoglobinuria, Paroxysmal
Study Drug
  • Drug: eculizumab
Date
Dec 2004 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
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
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Hemoglobinuria, Paroxysmal
Study Drug
  • Drug: eculizumab
Date
Dec 2004 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
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

Protocol Summary

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

Trial Locations

Location
Status
Location
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Status
N/A
Location
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305
Status
N/A
Location
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States, 06102
Status
N/A
Location
Cleveland Clinic Florida, Dept. of Clinical Research
Weston, Florida, United States, 33331
Status
N/A
Location
Indiana University Cancer Pavilion
Indianapolis, Indiana, United States, 46202
Status
N/A
Location
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21205
Status
N/A
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