Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia

Summary

Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

Timeline

Start

2014-11-12

Primary completion

2016-11-28

Completion

2016-11-28

Outcome

Mixed primary results

registry MEAN Gene Therapy HGF Plasmid (AMG0001): Change from Baseline at LOCF: -1.61 (Standard Deviation 2.863) score on a scale NCT02144610 ↗

registry MEAN Placebo: Change from Baseline at LOCF: -0.20 (Standard Deviation 3.087) score on a scale NCT02144610 ↗

registry analysis (superiority or other test); Gene Therapy HGF Plasmid (AMG0001) vs Placebo; p = 0.002; ANCOVA NCT02144610 ↗

registry analysis (superiority or other test); Gene Therapy HGF Plasmid (AMG0001) vs Placebo; p >0.999; Fisher Exact NCT02144610 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG0001	Other / unclassified	—	Intramuscular

Indications