NCT00060892

Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: AnGes USA, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 subject's ability to function without adverse consequences on quality of life.

Conditions

• Arterial Occlusive Disease
• Peripheral Vascular Disease
• Ischemia

Interventions

Type	Name	Description
GENETIC	HGF plasmid	Intramuscular injections into index leg on Days 0, 14, and 28

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-05-01
• Completion: 2007-01-01
• First posted: 2003-05-16
• Last updated: 2008-01-11

Locations

24 sites across 1 country: United States