NCT02016755

A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

A Phase IIB Pilot Study to Confirm the Feasibility and Tolerability of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AnGes USA, Inc. · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)

Detailed description

The primary objectives of the study are: 1. To confirm the feasibility of study-related activities and the tolerability of a modified dosage regimen of AMG0001 in CLI 2. To evaluate safety of AMG0001

Conditions

• Critical Limb Ischemia
• Vascular Diseases
• Peripheral Arterial Disease

Interventions

Type	Name	Description
BIOLOGICAL	HGF Plasmid	Intramuscular injection in the affected limb.

Timeline

• Start date: 2013-11-01
• Primary completion: 2018-03-31
• Completion: 2018-03-31
• First posted: 2013-12-20
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study