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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00221195 |
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Date of registration:
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19/09/2005 |
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Primary sponsor: |
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Public title:
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A Prospective, Randomized, Cross-Over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors
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Scientific title:
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Date of first enrolment:
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June 2003 |
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Target sample size:
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42 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00221195 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Cindy Leissinger, MD |
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Address:
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Telephone:
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504-390-2152 |
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Email:
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cleissi@cox-internet.com |
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Affiliation:
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Name:
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Cindy A Leissinger, MD |
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Address:
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Telephone:
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504-390-2152 |
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Email:
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cleissi@cox-internet.com |
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Affiliation:
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Name:
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Cindy A Leissinger |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tulane University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hemophilia A, any severity, with documented hisotry of high-titer inhibitor (>5BU);
current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/=
6 bleeds requiring bypassing therapy in the previous 6 months
Exclusion Criteria:
- concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet
count less than 100,000
Age minimum:
24 Months
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemophilia A With Inhibitors
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Intervention(s)
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Drug: activated prothrombin complex concentrate (FEIBA)
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Primary Outcome(s)
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Reduction in the number of bleeds
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Secondary ID(s)
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PRO-FEIBA Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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