Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00566657

Purpose

The primary objective of the study is to demonstrate the superiority of 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.

The secondary objectives of the study are to evaluate:

The efficacy of XRP0038/NV1FGF versus XRP0038/NV1FGF placebo for delaying the time to death.
The safety of XRP0038/NV1FGF in the study population

Condition	Intervention	Phase
Peripheral Vascular Diseases	Drug: XRP0038/NV1FGF Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: over 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events and laboratory parameters [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	490
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2012
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: XRP0038/NV1FGF intra-muscular injections
Placebo Comparator: 2	Drug: placebo intra-muscular injections

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 less than 70 mmHg and/or toe systolic pressure less than 50 mmHg or TcPO2 less than 30 mm Hg
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 SBP≥ 180 mmHg or 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 women or women of childbearing potential not protected by an effective contraceptive method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566657

Show 32 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with criticial limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. Epub 2011 Jun 21.

Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. Epub 2011 May 28.

Responsible Party:	ICD, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00566657 History of Changes
Other Study ID Numbers:	EFC6145, EudraCT 2006-006277-24
Study First Received:	November 30, 2007
Last Updated:	September 27, 2010
Health Authority:	United States: Food and Drug Administration Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Sanofi-Aventis:

Critical Limb Ischemia
Peripheral Artery Disease
Plasmid based gene therapy

Additional relevant MeSH terms:

Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes

Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 24, 2012