Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00122330 |
Date of registration:
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18/07/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
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Scientific title:
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Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients |
Date of first enrolment:
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October 2004 |
Target sample size:
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75 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00122330 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Canada
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France
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Germany
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Ireland
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Italy
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Netherlands
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Sweden
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Switzerland
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemoglobinuria, Paroxysmal
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Intervention(s)
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Drug: eculizumab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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