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

Critical Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974179
• Other study ID #: AG-CLI-0206-LTFU
• Secondary ID: 2016-003491-41
• Status: Completed
• Start date: February 20, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: March 2020
• Source: AnGes USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
AnGes USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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