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Completed

NCT Number: NCT02974179

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

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

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subjects from Study AG-CLI-0206 who received AMG0001

Biological

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

Primary outcomes

  1. Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AnGes USA, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2016
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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