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CompletedNCT00566657TAMARISUpdated May 2, 2016

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

A Phase 3 interventional study of riferminogene pecaplasmid and Placebo (for riferminogene pecaplasmid) in Peripheral Vascular Diseases, sponsored by Sanofi. Completed at 32 sites in 32 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
525
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Peripheral Vascular Diseases

Keywords

  • Critical Limb Ischemia
  • Peripheral Artery Disease
  • Plasmid based gene therapy
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 525 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
525 participants (actual)

Study arms

  • Experimental
    Riferminogene pecaplasmid

    4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals

    Biological: riferminogene pecaplasmid

  • Placebo comparator
    Placebo

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

    Biological: Placebo (for riferminogene pecaplasmid)

Interventions

  • Biologicalriferminogene 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

    Also known as: NV1FGF, XRP0038

  • BiologicalPlacebo (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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

32 sites
  • 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
    Sao Paulo, Brazil
  • Sanofi-Aventis Administrative Office
    Laval, Canada
  • Sanofi-Aventis Administrative Office
    Santiago, Chile
  • 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
  • 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
    Seoul, Korea, Republic of
  • Sanofi-Aventis Administrative Office
    Mexico, Mexico
  • Sanofi-Aventis Administrative Office
    Warszawa, Poland
  • Sanofi-Aventis Administrative Office
    Moscow, Russian Federation
  • Sanofi-Aventis Administrative Office
    Singapore, Singapore
  • 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
  • Sanofi-Aventis Administrative Office
    Guildford, Surrey, United Kingdom
08

References and documents

Publications

  • 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 critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21. PubMed 21696982 ↗
  • 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. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28. PubMed 21621834 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00566657
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Dec 3, 2007
Start date
Nov 2007
Primary completion
Aug 2010
Completion
Aug 2012
Last update
May 2, 2016

Study contacts

ICD CSD
study director · Sanofi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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