Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060892
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2003-05-15
Brief Title:
Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia
Sponsor:
AnGes USA Inc
Organization:
AnGes USA Inc
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
Status:
COMPLETED
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 primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 HGF transferred via plasmid vector as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia CLI This study also evaluated the improvement in wound healing without adverse effects on the quality of life as well as the potential reduction of amputation mortality and rest pain in the CLI population
Detailed Description:
The primary goal of this study was to assess the safety of AMG0001 detect potential angiogenesis response to AMG0001 treatment and to correlate these changes to clinical endpoints dependent upon improvement in tissue perfusion for relief of CLI complications The objectives of this study were to
Assess the overall safety of different exposure regimens of AMG0001 in the CLI subject population
Evaluate the potential effect of angiogenesis associated with different doses and dose regimens of AMG0001 as measured by improvement in tissue perfusion
Evaluate the activity of different exposure regimens of AMG0001 to benefit clinical outcomes of reduction of amputation and mortality wound healing rest-pain reduction and improvement in subjects ability to function without adverse consequences on quality of life
Assess the overall safety of different exposure regimens of AMG0001 in the CLI subject population
Evaluate the potential effect of angiogenesis associated with different doses and dose regimens of AMG0001 as measured by improvement in tissue perfusion
Evaluate the activity of different exposure regimens of AMG0001 to benefit clinical outcomes of reduction of amputation and mortality wound healing rest-pain reduction and improvement in subjects ability to function without adverse consequences on quality of life
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