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

Completed · Phase 3 · Has a placebo group

Conditions studied: Peripheral Vascular Diseases

In brief

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.

Key facts

Study ID

NCT00566657

Run by

Sanofi

People needed

525

Starts

2007-11-01

Expected to finish

2012-08-01

Last updated by the study team

2016-05-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene);
• With objective evidence of CLI such as ankle systolic pressure <70 mmHg and/or toe systolic pressure <50 mmHg or transcutaneous oxygen pressure (TcPO2) <30 mmHg;
• Unsuitable for standard revascularization of his/her peripheral arterial disease;
• Having a negative screening for cancer.

You may not qualify if…

• Previous major amputation on the leg to be treated or planned major amputation within the first month following randomization;
• Known Buerger's disease;
• Successful lower extremity revascularization procedure within 3 months prior randomization;
• Uncontrolled blood pressure defined as systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg despite adequate antihypertensive treatment;
• Acute cardiovascular events within 3 months prior to randomization;
• Active proliferative retinopathy and severe macular oedema;
• Previous or current history of malignant disease within the past 5 years;
• Previous treatment with systemic angiogenic factors or with stem cells therapy;
• Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control. Man not following effective contraceptive method with his partner of childbearing potential during the course of the study.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Macquarie Park, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Minsk, Belarus
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Tatari, Estonia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Causeway Bay, Hong Kong
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Tokyo, Japan
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Singapore, Singapore
• Sanofi-Aventis Administrative Office — Midrand, South Africa

Full record on ClinicalTrials.gov

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