Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00004779|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis (CF).
II. Determine whether ion transport abnormalities in CF airway cells can be corrected.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Genetic: Ad5-CB-CFTR||Phase 1|
Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR, a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene. Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Study Start Date :||January 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004779
|Study Chair:||Michael R. Knowles||University of North Carolina|