Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073463
Status:
TERMINATED
Last Update Posted:
2008-01-28
First Post:
2003-11-21
Brief Title:
Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis
Sponsor:
Targeted Genetics Corporation
Organization:
Targeted Genetics Corporation
Study Overview
Official Title:
A Multicenter Double-Blind Placebo Controlled Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis
Status:
TERMINATED
Status Verified Date:
2008-01
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:
The purpose of this study is to confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of Cystic Fibrosis CF
Detailed Description:
Cystic Fibrosis is an autosomal recessive disorder with an incidence of approximately 1 in 33000 live births It is due to defects in the CFTR gene which is located on chromosome 7 Gene Therapy holds the promise of addressing the primary defect in CF by reconstituting the CFTR function in the lung tgAAVCF which has been genetically engineered to contain the CFTR gene has been extremely well tolerated following single and multiple dose administrations to the nose sinus and lung Dose-dependent gene transfer has been demonstrated Although vector gene expression has not been detected evidence consistent with biological activity was observed in maxillary sinus study and statistically significant changes in the FEV1 and IL-8 levels were observed in the recently completed multidose aerosol study These findings are worthy of further investigation
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 |
|---|---|---|---|
| RAC-0301-569 | None | None | None |