Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT00424866
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2007-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
Sponsor:
CardioVascular BioTherapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
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:
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.
Detailed Description:
FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: