Study to assess the long term safety of subjects who have been treated with AMG0001

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003491-41-HU

Enrollment

Registered

2016-10-12

Start date

2016-12-12

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical limb ischemia MedDRA version: 19.0 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866

Interventions

Product Name: Hepatocyte Growth Factor (HGF) cDNA Plasmid Product Code: AMG0001 (plasmid pVAX1HGF/MGBI) Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects who have been treated with AMG0001 in the AG-CLI-0206 study. 2. Subjects who have provided consent for the long term follow-up study either directly or through a legally authorized representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subjects who were not enrolled in the AG-CLI-0206 study. 2. Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001. 3. Subjects who have not provided consent for the long term follow-up study either directly or through a legally authorized representative.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001;Secondary Objective: ;Primary end point(s): The primary objective of this study is to fulfill the long term safety reporting requirements from health authorities of clinical studies that use a gene therapy investigational product.;Timepoint(s) of evaluation of this end point: Subjects complete questionnaire every 6 months for a total follow-up period of approximately 3 yrs.	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001;Secondary Objective: ;Primary end point(s): The primary objective of this study is to fulfill the long term safety reporting requirements from health authorities of clinical studies that use a gene therapy investigational product.;Timepoint(s) of evaluation of this end point: Subjects complete questionnaire every 6 months for a total follow-up period of approximately 3 yrs.

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Secondary

Measure	Time frame
Secondary end point(s): This is a long term follow up study for regulatory purposes and there is no secondary endpoint.	—

Countries

Belgium, Canada, France, Hungary, United States

Contacts

Public ContactHiroyuki Suda

AnGes Inc.

hsuda@anges-inc.com+1240630-1255

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026