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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: |
NCT01402531 |
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Date of registration:
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19/07/2011 |
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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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Submucosal Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
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Scientific title:
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Submucosal Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT) |
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Date of first enrolment:
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July 22, 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01402531 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults over the age of 18, both male and non-pregnant females capable of making
informed consent who have HHT by Curacao criteria and whose nasal bleeding due to HHT
is of such a magnitude that it requires medical care.
- Females of childbearing age will be given a pregnancy test as a preliminary measure to
ensure that those who become involved are not at risk.
- Generally these patients will have an ESS score of 5 or greater. However on occasion
an individual with a score between 2 and 5 but not capable of cleansing their nose
adequately to be involved in a Bevacizumab spray treatment may be included.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Hemorrhagic Telangiectasia (HHT)
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Intervention(s)
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Drug: Submucosal Bevacizumab
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Primary Outcome(s)
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Epistaxis Using the Epistaxis Severity Score, Hematocrit, Hemoglobin and Serum Feritin Levels..
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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