NCT02974179

A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: AnGes USA, Inc. · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

Detailed description

The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	Subjects from Study AG-CLI-0206 who received AMG0001	Subjects from Study AG-CLI-0206 who received the study product AMG0001

Timeline

• Start date: 2017-02-20
• Primary completion: 2020-01-10
• Completion: 2020-01-10
• First posted: 2016-11-28
• Last updated: 2020-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study