Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004287
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase I Study of the Third Generation Adenovirus H5001CBCFTR in Patients With Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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
I Assess the safety and feasibility of gene transfer with the third generation adenovirus H5001CBCFTR in patients with cystic fibrosis
I Assess the safety and feasibility of gene transfer with the third generation adenovirus H5001CBCFTR in patients with cystic fibrosis
Detailed Description:
PROTOCOL OUTLINE H5001CBCFTR an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene is administered endobronchially
Cohort of 2 patients receive 1 of 6 H5001CBCFTR concentrations There is no intrapatient dose escalation
Cohort of 2 patients receive 1 of 6 H5001CBCFTR concentrations There is no intrapatient dose escalation
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPHS-28051 | None | None | None |