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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00566657
First received: November 30, 2007
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

Enrollment: 526
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: September 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
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

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

Responsible Party: Sanofi
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 3, 2012
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Russia: Ministry of Health of the Russian Federation

Keywords provided by Sanofi:
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 22, 2013