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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 90
Updated:1/27/2019
Start Date:February 20, 2017
End Date:February 2019

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

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.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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mi
from
Lebanon, NH
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