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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: |
NCT00073463 |
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Date of registration:
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21/11/2003 |
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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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Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis
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Scientific title:
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A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis |
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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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100 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00073463 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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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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Eligible subjects will be randomized to two aerosolized doses of either tgAAVCF or placebo
30 days apart. Subjects will undergo pulmonary function testing every two weeks during the
active portion of the study (three months) and will be followed for safety for a total of
seven months.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Genetic: tgAAVCF
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Secondary ID(s)
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RAC-0301-569
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25E01
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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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