Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189540
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2005-09-12
Brief Title:
Study of Hepatocyte Growth Factor HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers
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 Limb Ischemia in Subjects Who Have Peripheral Ischemic Ulcers
Status:
COMPLETED
Status Verified Date:
2021-10
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 objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing reduction in amputation improved pain at rest and hemodynamic measurement and to assess the effectiveness of the administrative method
Detailed Description:
The primary goals of this study evaluating AMG0001 administration in CLI subjects will be to investigate the efficacy and safety of AMG0001 Specifically the objectives are
1 Assess efficacy of a dosing regimen of 40mg3 mL AMG0001 administered on Days 0 14 and 28 as measured by reduction in total wound area at Month 3
2 Assess potential effects of angiogenesis associated with a dosing regimen of 40mg3 mL AMG0001 administered on Days 0 14 and 28 as measured by reduction in total wound area at Months 6 and 12 along with reduction in major amputations and improved pain at rest as measured on the VAS and hemodynamic measures ABITBI at Month 3 and Month 6
3 Assess overall safety of AMG0001 in the Critical Limb Ischemia subject population as determined by physical examination blood and urine analyses electrocardiogram vital signs and by evaluation of adverse experiences during and after the course of treatment
1 Assess efficacy of a dosing regimen of 40mg3 mL AMG0001 administered on Days 0 14 and 28 as measured by reduction in total wound area at Month 3
2 Assess potential effects of angiogenesis associated with a dosing regimen of 40mg3 mL AMG0001 administered on Days 0 14 and 28 as measured by reduction in total wound area at Months 6 and 12 along with reduction in major amputations and improved pain at rest as measured on the VAS and hemodynamic measures ABITBI at Month 3 and Month 6
3 Assess overall safety of AMG0001 in the Critical Limb Ischemia subject population as determined by physical examination blood and urine analyses electrocardiogram vital signs and by evaluation of adverse experiences during and after the course of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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