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Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00566657•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (32)

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

Key Dates

Start Date

November 1, 2007

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2012

Last Updated

May 2, 2016

Enrollment

525

ACTUAL participants

Conditions

Peripheral Vascular Diseases

Interventions

riferminogene pecaplasmid

BIOLOGICAL

Placebo (for riferminogene pecaplasmid)

BIOLOGICAL

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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