Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00004287|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Genetic: H5.001CBCFTR||Phase 1|
PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially.
Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||14 participants|
|Study Start Date :||November 1995|
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): NCT00004287
|Study Chair:||James M. Wilson||University of Pennsylvania|