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

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

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AnGes USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: AG-CLI-0206-LTFU; 2016-003491-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No