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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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19 February 2015 |
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Main ID: |
NCT01031992 |
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Date of registration:
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11/12/2009 |
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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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Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
TAHHT |
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Scientific title:
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Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01031992 |
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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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Urban W Geisthoff, Priv.-Doz. Dr.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.
Exclusion Criteria:
- pregnant,
- minor,
- had an increased risk of thrombotic events (history or signs of cerebrovascular
events, cardiac arrhythmias, biochemically increased coagulation parameters),
- renal insufficiency,
- a history of massive hematuria or defects of color vision.
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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Hereditary Hemorrhagic Telangiectasia
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Intervention(s)
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Drug: Tranexamic acid first, than placebo
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Drug: First placebo, than Tranexamic acid.
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Primary Outcome(s)
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Change of hemoglobin level within the phases.
[Time Frame: Beginning and end of each 3 months period.]
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Secondary Outcome(s)
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Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)
[Time Frame: Measured once a day during each 3 months period]
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Secondary ID(s)
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141CHC9008-001
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TAHHT
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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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