Peripheral Vascular Diseases Clinical Trial
Official title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid over
placebo in the prevention of major amputation above the ankle of the treated leg or of death
from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin
lesions.
Secondary objectives are to evaluate:
- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major
amputation;
- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to
death;
- The safety of riferminogene pecaplasmid in the study population.
The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up
contact is then scheduled 6 months later.
Per protocol amendment a 18-month long-term safety survey was added.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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