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 |
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the
AG-CLI-0206-LTFU study
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.
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
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Click here to add this to my saved trials
