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Trial record 1 of 3 for:    TAMARIS
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Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions (TAMARIS)

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ClinicalTrials.gov Identifier: NCT00566657
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Biological: riferminogene pecaplasmid Biological: Placebo (for riferminogene pecaplasmid) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Riferminogene pecaplasmid
4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals
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

Other Names:
  • NV1FGF
  • XRP0038

Placebo Comparator: Placebo
4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals
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

Primary Outcome Measures :
  1. Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: From randomization up to 12 months ]

Secondary Outcome Measures :
  1. Time to first major amputation of the treated leg [ Time Frame: From randomization up to 12 months ]
  2. Time to death from any cause [ Time Frame: From randomization up to 12 months ]
  3. Number of participants with adverse events as a measure of safety [ Time Frame: From 1st treatment administration up to death, or the earliest of Day 360 or last contact/assessment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566657

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos AIres, Argentina
Australia, New South Wales
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
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Horsholm, 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
Hong Kong
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
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sanofi-Aventis Administrative Office
Kiev, Ukraine
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications of Results:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00566657    
Other Study ID Numbers: EFC6145
2006-006277-24 ( EudraCT Number )
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: March 2016
Keywords provided by Sanofi:
Critical Limb Ischemia
Peripheral Artery Disease
Plasmid based gene therapy
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases