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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003491-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who received AMG0001 | Subjects from Study AG-CLI-0206 who received the study product AMG0001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjects from Study AG-CLI-0206 who received AMG0001 | Biological | Subjects from Study AG-CLI-0206 who received the study product AMG0001 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001 | A health questionnaire will be used to collect specific information from the subject every 6 months | 3 years from the date last subject randomized into AG-CLI-0206 study |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Powell, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |