Contact SCGE




Clinical Trial Report

Gene Therapy Trial Report

Summary

Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia

NCTID NCT02144610 (View at clinicaltrials.gov)
Description
Development Status Inactive
Indication Critical Limb Ischemia
Disease Ontology Term DOID:0050852
Compound Name COLLATEGENE
Compound Alias beperminogene perplasmid, AMG001
Sponsor AnGes USA, Inc.
Funder Type Industry
Recruitment Status
Terminated
Enrollment Count 46
Results Posted View Results

Therapy Information

Target Gene/Variant HGF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intramuscular
Drug Product Type Plasmid
Target Tissue/Cell
Delivery System None (naked plasmid)
Vector Type
Editor Type
Dose 1 0.4mg (3X: day 0, 14, 28)
Dose 2 4.0mg (2X: day 0, day 28)
Dose 3 4.0mg (3X: day 0, day 14, day 28)
Dose 4
Dose 5

Study Record Dates

Current Stage Phase3
Submit Date 2014-05-20
Completion Date 2016-11-28
Last Update 2019-08-13

Participation Criteria

Eligible Age 40 Years - 90 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 60
Locations Canada,Netherlands,Sweden,Belgium,Hungary,United States,Finland,Denmark,Poland,Italy,France

Regulatory Information

Has US IND True
FDA Designations
Recent Updates Product was approved in Japan in 2019, marketing application has since been withdrawn

Resources/Links

News and Press Releases
Related NCTID