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

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Biological: Subjects from Study AG-CLI-0206 who received AMG0001

• Registration Number: NCT02974179
• Lead Sponsor: AnGes USA, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-28
• Study Start: 2017-02-20
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States