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

NCT02974179 | Completed FDA Drug

• 2 other identifiers: AG-CLI-0206-LTFU2016-003491-41
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Subjects from Study AG-CLI-0206 who received AMG0001 BIOLOGICAL

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

Subjects who received AMG0001

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnGes USA, Inc.: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Richard Powell, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: February 20, 2017
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)