Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis
|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)|
|Estimated Enrollment :||14 participants|
|Study Start Date :||November 1995|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004287
|Study Chair:||James M. Wilson||University of Pennsylvania|