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Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients


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

Thank you

Trial Information

Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Authority:

United States: Food and Drug Administration

Study ID:

TRIUMPH

NCT ID:

NCT00122330

Start Date:

October 2004

Completion Date:

January 2006

Related Keywords:

  • Hemoglobinuria, Paroxysmal
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Scripps Cancer CenterLa Jolla, California  92037
Stanford University Medical Center, Division of HematologyStanford, California  94305-5112
University of California at Los AngelesLos Angeles, California  90095
Hartford Hospital, Cancer Clinical Research OfficeHartford, Connecticut  06102
Johns Hopkins University Medical CenterBaltimore, Maryland  21205
NYU Clinical Cancer CenterNew York, New York  10016
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis ProgramPhiladelphia, Pennsylvania  19104
City of Hope National Medical Center, Div. of Hematology & Bone Marrow TransplantDuarte, California  91010-3000
Cleveland Clinic, Dept. of Clinical ResearchWeston, Florida  33331
Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/ImmunologyIndianapolis, Indiana  46202
National Heart, Blood, and Lung Institute, National Institutes of HealthBethesda, Maryland  20892
Washington University School of Medicine, Dept. of Internal Medicine/Division of HematologySt. Louis, Missouri  63110-1093
Duke University Health System, Division of Cell Therapy, Heme Malignancies ProgramDurham, North Carolina  27710