Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004498
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency
Sponsor:
University of Pennsylvania
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2000-02
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 Determine the safety feasibility and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency
I Determine the safety feasibility and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency
Detailed Description:
PROTOCOL OUTLINE This is a dose escalation study Patients undergo a femoral arterial placement of a hepatic intraarterial catheter Patients then receive adenoviral vector mediated gene transfer intravascularly over 30 minutes
Cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined
Patients are followed at 3 5 7 8 15 and 29 days at 2 months and then every 3 months thereafter
Completion date provided represents the completion date of the grant per OOPD records
Cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined
Patients are followed at 3 5 7 8 15 and 29 days at 2 months and then every 3 months thereafter
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| UPSM-FDR001529 | None | None | None |