ClinicalTrials.Veeva

Menu

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

A

AnGes

Status

Completed

Conditions

Critical Limb Ischemia

Treatments

Biological: Subjects from Study AG-CLI-0206 who received AMG0001

Study type

Observational

Funder types

Industry

Identifiers

NCT02974179
AG-CLI-0206-LTFU
2016-003491-41 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

9 participants in 1 patient group

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems