NCT00566657

Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) 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.

Detailed description

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.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
BIOLOGICAL	riferminogene pecaplasmid	Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated
BIOLOGICAL	Placebo (for riferminogene pecaplasmid)	Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-08-01
• Completion: 2012-08-01
• First posted: 2007-12-03
• Last updated: 2016-05-02

Locations

32 sites across 32 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom