Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00004806|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 30, 2011
Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Genetic: Cystic fibrosis transmembrane conductance regulator||Phase 1|
PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control.
Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid.
Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Study Start Date :||June 1995|
|Primary Completion Date :||November 2002|
|Study Completion Date :||November 2002|
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): NCT00004806
|Study Chair:||Eric J. Sorscher||University of Alabama at Birmingham|