Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Study Identifier:
TRIUMPH
ClinicalTrials.gov Identifier:
NCT00122330
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
Oct 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
  • 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 Criteria
  • 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
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Hemoglobinuria, Paroxysmal
Study Drug
  • Drug: eculizumab
Date
Oct 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
  • 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 Criteria
  • 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

Protocol Summary

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

Trial Locations

Location
Status
Location
City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant
Duarte, California, United States, 91010-3000
Status
N/A
Location
University of California at Los Angeles
Los Angeles, California, United States, 90024
Status
N/A
Location
Scripps Cancer Center
San Diego, California, United States, 92121
Status
N/A
Location
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305-5821
Status
N/A
Location
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States, 06102
Status
N/A
Location
Cleveland Clinic, Dept. of Clinical Research
Weston, Florida, United States, 33331
Status
N/A
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