AG-CLI-0206: Ph 3 - Efficacy & Safety Study for Critical Limb Ischemia
Research type
Research Study
Full title
AG-CLI-0206 A Phase 3 Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects with Critical Limb Ischemia
IRAS ID
162545
Contact name
Clifford Paul Shearman
Contact email
Sponsor organisation
AnGes Inc.
Eudract number
2014-001129-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 1 days
Research summary
This is a clinical trial of an experimental study drug (a gene medicinal product called Hepatocyte Growth Factor (HGF) Plasmid, named AMG0001) for patient with blocked arteries in lower limbs that reduces blood flow to leg and foot (a medical condition called Critical Limb Ischaemia, CLI).
The aim of the study is to measure safety and effectiveness of study drug against that of dummy drug (placebo). Approximately 100 sites will participate globally, with enrollment target of 500 CLI patients.
Patients eligible for study are aged 40 to 90, with blocked arteries of lower limb with no option or a poor option for clearing the artery by surgical bypass or also have no option for revascularisation by insertion of a small wire.
Patients will be assessed at a screening visit for suitability for in the study, and will then have a further 19 visits over 18 months. The study drug or placebo will be injected into the affected leg. The choice as to which drug injection the patient will receive will be made by computer (randomisation) and neither patient or study doctor will know the outcome from the computer. Randomisation will be a ratio 1:1, which means that the patient will have an equal chance of receiving study drug or dummy drug.
Follow-up data for the effectiveness of each endpoint and revascularisation of the affected limb will be obtained by utilising a questionnaire every 3 months until the last patient enrolled completes the 18 Month Visit.
Safety follow-up data will be obtained for all patients by also using a questionnaire every 3 months for a minimum 1.5 years after the 18 Month Visit.
The total duration of the study will be 18 months for clinic visits and up to approximately
24 months including the questionnaire portion.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0143
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion