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Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

Peripheral Artery Disease Clinical Trial

Official title:
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity

Clinical Trial Summary

This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

Clinical Trial Description

This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups: - 4.0 mg AMG0001 intramuscular (IM) (n = 20) - 8.0 mg AMG0001 IM (n = 20) - Placebo IM (n = 20) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04267640
Study type Interventional
Source AnGes USA, Inc.
Contact Melton Affrime, PharmD
Phone +1 908-444-3889
Email maffrime@anges.co.jp
Status Recruiting
Phase Phase 2
Start date January 30, 2020
Completion date January 2023
View Details
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