Peripheral Vascular Disease Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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