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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02974179

Enrollment

Registered

2016-11-28

Start date

2017-02-20

Completion date

2020-01-10

Last updated

2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Brief 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.

Interventions

BIOLOGICALSubjects from Study AG-CLI-0206 who received AMG0001

Subjects from Study AG-CLI-0206 who received the study product AMG0001

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Subjects who have been treated with AMG0001 in the AG-CLI-0206 study. * Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative. * Subjects who have provided a release of information to the sponsor.

Exclusion criteria

* Subjects who were not enrolled in the AGCLI-0206 study. * Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001. * Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative. * Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

Design outcomes

Primary

Measure	Time frame	Description
Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001	3 years from the date last subject randomized into AG-CLI-0206 study	A health questionnaire will be used to collect specific information from the subject every 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026