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

• Sponsor: AnGes USA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02974179
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Actual Duration (Months): 34.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Critical Limb Ischemia	Biological: Subjects from Study AG-CLI-0206 who received AMG0001

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 9 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
• Actual Study Start Date: Feb 20, 2017
• Actual Primary Completion Date: Jan 10, 2020
• Actual Study Completion Date: Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Subjects who received AMG0001 Subjects from Study AG-CLI-0206 who received the study product AMG0001	Biological: Subjects from Study AG-CLI-0206 who received AMG0001; Subjects from Study AG-CLI-0206 who received the study product AMG0001

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• AnGes USA, Inc.

Investigators

• Principal Investigator: Richard Powell, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AnGes USA, Inc.
• ClinicalTrials.gov Identifier: NCT02974179
• Other Study ID Numbers: AG-CLI-0206-LTFU; 2016-003491-41
• First Posted: Nov 28, 2016
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Mar 12, 2020