Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004806
Status:
COMPLETED
Last Update Posted:
2011-03-30
First Post:
2000-02-24
Brief Title:
Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-11983 | None | None | None |