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: |
NCT00783523 |
Date of registration:
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30/10/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Influence of MMP on Brain AVM Hemorrhage
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Scientific title:
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Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage |
Date of first enrolment:
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March 2008 |
Target sample size:
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33 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00783523 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 1
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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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Chanhung Lee, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 13 years or older
- Female patients of child bearing age using barrier-type birth control
- Creatinine no greater than 2.0 mg/di
- Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal
- WBC count at least 3,800/mm3
- BMI within 50% of normal
Exclusion Criteria:
- Allergy to tetracycline
- Unstable medical illness (unstable angina, advanced cancer, etc) over the last 30
days
- Female patients of child-bearing age not using effective birth control (barrier)
- History of vestibular disease (except benign positional vertigo)
- History of noncompliance with treatment or other experimental protocols
- Patients taking other antibiotics
- History of systemic lupus erythematosis
- Patients who are immunocompromised Patients with clinically significant hepatic
dysfunction
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arteriovenous Malformations
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Cavernous Angiomas
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Brain Aneurysms
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Intervention(s)
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Drug: Doxycycline or Placebo
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Primary Outcome(s)
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Our primary aim is to perform a pilot study to document the effect of doxycycline therapy to decrease MMP expression in the vascular malformation tissue.
[Time Frame: 1 to 2-week pre-operative]
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Secondary Outcome(s)
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Our secondary aims are: (1) To explore whether plasma MMP-9 levels can be used as a marker for MMP-9 inhibition in the vascular malformation lesional tissue
[Time Frame: 1 to 2-week pre operative]
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Secondary ID(s)
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H42145-30334-02
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AHA #0730360N
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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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