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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00640289 |
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Date of registration:
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17/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial of Factor XIII (FXIII) Concentrate
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Scientific title:
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Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency |
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Date of first enrolment:
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January 2000 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00640289 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Diane J. Nugent, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Orange Co. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients may be of either sex or age. Children and newborn infants are specifically
included in this study.
- Patient must have documented congenital Factor XIII deficiency
- Patient or legal guardian must sign informed consent
- Patients who have negative serology for hepatitis B should receive Hepatitis B
vaccination.
Exclusion Criteria:
- Patient has acquired Factor XIII deficiency
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Factor XIII Deficiency
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Hemophilia
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Intervention(s)
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Drug: Fibrogammin P
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Primary Outcome(s)
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Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions
[Time Frame: Within 12 hours of FXIII infusion]
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Secondary Outcome(s)
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Surgical Efficacy Assessments With Factor XIII
[Time Frame: During surgical procedure]
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Secondary ID(s)
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BB-IND5986
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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